This section highlights FDA-related milestones and regulatory updates for drugs developed by Astrazeneca (AZN).
Over the past two years, Astrazeneca has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Durvalumab, datopotamab, NeXT, Datopotamab, Enhertu, ENHERTU®, and CALQUENCE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Durvalumab FDA Regulatory Timeline and Events
Durvalumab is a drug developed by Astrazeneca for the following indication: Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Durvalumab
- Announced Date:
- February 5, 2026
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AIM ImmunoTech Inc today reported positive data in a year-end update from the ongoing Phase 2 clinical study evaluating AIM's drug Ampligen® (rintatolimod) combined with AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the "DURIPANC" study) (see: ClinicalTrials.gov NCT05927142). .
AI Summary
AIM ImmunoTech reported positive year-end results from the ongoing Phase 2 DURIPANC study (NCT05927142) testing Ampligen® (rintatolimod) combined with AstraZeneca’s Imfinzi® (durvalumab) in metastatic pancreatic cancer patients who had stable disease after FOLFIRINOX. The company said the combination produced encouraging signals without significant toxicity, an important safety finding for patients in a post‑chemotherapy setting. Patients treated with Ampligen also consistently reported “high quality of life” during therapy, according to the update.
The company noted patent protection and orphan drug designations that could offer market exclusivity and potential commercial value if the treatment succeeds. While the interim data are promising for this large unmet medical need, final efficacy results and broader confirmatory data from the ongoing trial are still awaited.
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- November 26, 2025
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca's IMFINZI® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been approved in the US for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.
AI Summary
AstraZeneca's IMFINZI® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) is approved in the US for adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The approved perioperative regimen uses IMFINZI with FLOT before surgery (neoadjuvant), IMFINZI with FLOT after surgery (adjuvant), and then IMFINZI alone as maintenance therapy.
The approval is based on MATTERHORN Phase III results showing a 29% reduction in the risk of disease progression, recurrence or death versus chemotherapy alone (EFS HR 0.71; 95% CI 0.58–0.86; P<0.001) and a 22% reduction in the risk of death (OS HR 0.78; 95% CI 0.63–0.96; P=0.021). Estimated 3‑year overall survival was 69% with the IMFINZI regimen versus 62% with FLOT alone. Safety was consistent with known profiles of the treatments and rates of serious or Grade ≥3 events were similar between arms.
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- October 17, 2025
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
Positive results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca's IMFINZI® (durvalumab) in combination with standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS) versus chemotherapy alone.
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- October 13, 2025
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca advances its ambition to redefine cancer care with new data across its diverse, industry-leading portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress, October 17-21, 2025.
AI Summary
At the European Society for Medical Oncology (ESMO) Congress, October 17–21, 2025, AstraZeneca advances its ambition to redefine cancer care by presenting new results across its diverse, industry-leading portfolio and pipeline. More than 95 abstracts will feature nine approved medicines and nine potential new treatments.
Two late-breaking Presidential Symposium presentations—DESTINY-Breast11 and DESTINY-Breast05—underscore ENHERTU®’s promise in HER2-positive early breast cancer. TROPION-Breast02 data will demonstrate DATROWAY®’s potential in metastatic triple-negative breast cancer, the most aggressive subtype.
POTOMAC disease-free survival results and MATTERHORN overall survival findings will showcase IMFINZI®’s benefits in early bladder cancer and gastric cancer, respectively.
Additional studies on emerging molecules—such as the PARP inhibitor saruparib in prostate cancer, the folate receptor-targeted ADC torvu-sam in ovarian cancer, and the PD-1/TIGIT bispecific antibody rilvegostomig in non-small cell lung cancer—highlight AstraZeneca’s next wave of oncology innovation.
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- July 28, 2025
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca announced that supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and granted Priority Review in the US for the treatment of patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- June 1, 2025
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca announced Positive results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca's IMFINZI®(durvalumab) in combination with standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) versus chemotherapy alone.
AI Summary
AstraZeneca announced positive results from the MATTERHORN Phase III trial. The study found that combining IMFINZI® (durvalumab) with standard-of-care FLOT chemotherapy before and after surgery significantly improved event-free survival (EFS) compared to chemotherapy alone. In the trial, over two-thirds (67.4%) of patients receiving the IMFINZI-based regimen were free from disease progression or recurrence at two years, compared to 58.5% for those treated with only chemotherapy. This combination reduced the risk of disease progression, recurrence, or death by 29% (hazard ratio of 0.71 with p<0.001) and showed a strong trend toward improved overall survival. The MATTERHORN trial marks the first immunotherapy approach in this setting to demonstrate statistically significant EFS improvement, potentially setting a new standard of care for patients with resectable early-stage to locally advanced gastric and gastroesophageal junction cancers.
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- May 21, 2025
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca advances its ambition to eliminate cancer as a cause of death with new data across its diverse, industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 to June 3, 2025.
AI Summary
AstraZeneca is set to showcase new data at the ASCO Annual Meeting from May 30 to June 3, 2025, underscoring its ambitious mission to eliminate cancer as a cause of death. The company will present breakthrough results from multiple Phase III trials across its extensive oncology portfolio and pipeline, highlighting innovative treatments for several cancer types including breast, gastric, and lung cancers. The data demonstrate promising advances with novel therapies such as camizestrant, a next-generation oral SERD, and other immuno-oncology combinations that could transform the cancer treatment landscape.
With over 80 abstracts slated for presentation, AstraZeneca’s industry-leading portfolio and robust pipeline reflect its commitment to improving patient outcomes worldwide. Company executives emphasized that these developments are a major step forward in redefining cancer care, fueling hope for a future where cancer may eventually be overcome.
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- March 31, 2025
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca's IMFINZI® (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZIas adjuvant monotherapyafter radical cystectomy (surgery to remove the bladder) has been approved in the US for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).
AI Summary
AstraZeneca’s IMFINZI® (durvalumab), when given with chemotherapy drugs gemcitabine and cisplatin before surgery, followed by IMFINZI alone after radical cystectomy, has received US FDA approval for treating adult patients with muscle-invasive bladder cancer (MIBC). This new perioperative treatment is based on the NIAGARA Phase III trial, which showed a 32% reduction in the risk of disease recurrence and a 25% decrease in the risk of death compared to chemotherapy alone.
The approval marks an important breakthrough for MIBC patients, nearly half of whom face cancer recurrence after standard treatments. With these promising results, the durvalumab regimen may offer a new standard of care, improving survival and transforming treatment strategies for this challenging condition.
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- March 7, 2025
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca announced Positive high-level results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca's IMFINZI® (durvalumab) in combination with standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS).
AI Summary
AstraZeneca announced positive high-level results from the MATTERHORN Phase III trial, which evaluated a perioperative treatment for patients with resectable gastric and gastroesophageal junction cancers. In the study, patients received IMFINZI® (durvalumab) combined with the standard FLOT chemotherapy regimen before and after surgery, followed by IMFINZI monotherapy. The trial met its primary endpoint by showing a statistically significant and clinically meaningful improvement in event-free survival (EFS) compared to chemotherapy alone. In earlier analyses, the combination more than doubled the pathologic complete response rate. These findings suggest that adding IMFINZI to the standard chemotherapy not only lowers the risk of cancer coming back but also offers a promising new treatment approach for patients with these challenging cancers.
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- December 5, 2024
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca's IMFINZI® (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
AI Summary
The US Food and Drug Administration (FDA) has approved AstraZeneca’s IMFINZI® (durvalumab) for adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after undergoing concurrent platinum-based chemotherapy and radiation therapy. This approval is based on results from the ADRIATIC Phase III trial, which demonstrated a 27% reduction in the risk of death compared to placebo. The trial also showed improved overall survival, providing a significant benefit for patients with this aggressive form of lung cancer that traditionally has a poor prognosis. IMFINZI now offers the first immunotherapy option in this setting, marking an important advancement in treatment, as it is the only approved immunotherapy for both limited- and extensive-stage small cell lung cancer. The FDA awarded the therapy Priority Review and Breakthrough Therapy Designation, highlighting its potential as a practice-changing treatment for LS-SCLC.
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- August 16, 2024
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca announced that IMFINZI® (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
AI Summary
AstraZeneca announced that its IMFINZI® (durvalumab), when used with chemotherapy, has received FDA approval for treating adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer that does not have EGFR mutations or ALK rearrangements. This treatment involves using IMFINZI alongside neoadjuvant chemotherapy before surgery and then continuing as monotherapy after the procedure.
The approval was based on results from the AEGEAN Phase III trial, which showed that the IMFINZI-based regimen reduced the risk of cancer recurrence, progression, or death by 32% compared to chemotherapy alone. These findings highlight the treatment’s potential to improve outcomes in early-stage lung cancer, marking a significant advancement in helping patients achieve a curative-intent approach in their care.
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- August 15, 2024
- Target Action Date:
- Q4 2024
- Estimated Target Date Range:
- October 1, 2024 - December 31, 2024
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca announced that The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2024.
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- August 15, 2024
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca announced that supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab), based on the results from the positive ADRIATIC Phase III trial in patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based concurrent chemoradiotherapy (cCRT), has been accepted
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- August 15, 2024
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca announced that supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) granted Priority Review in the US.
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- August 14, 2024
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca announced that have been approved in the European Union (EU) as treatment for certain patients with primary advanced or recurrent endometrial cancer.
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- June 25, 2024
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca announced the Positive high-level results from the NIAGARA Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint of overall survival (OS) versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer (MIBC).
Read Announcement- Drug:
- Durvalumab
- Announced Date:
- June 17, 2024
- Indication:
- Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Announcement
AstraZeneca plc’s ancer drug, Imfinzi (durvalumab), in conjunction with standard chemotherapy, has now received endorsement from the U.S. authorities for treating certain severe forms of endometrial cancer.
Read Announcement
Datopotamab deruxtecan-dlnk FDA Regulatory Timeline and Events
Datopotamab deruxtecan-dlnk is a drug developed by Astrazeneca for the following indication: For patients with previously treated metastatic HR-positive, HER2-negative breast cancer.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- datopotamab deruxtecan-dlnk
- Announced Date:
- February 3, 2026
- Indication:
- For patients with previously treated metastatic HR-positive, HER2-negative breast cancer
Announcement
Daiichi Sankyo and AstraZeneca's supplemental Biologics License Application (sBLA) for DATROWAY® (datopotamab deruxtecan-dlnk) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
AI Summary
The U.S. FDA has accepted Daiichi Sankyo and AstraZeneca’s supplemental Biologics License Application (sBLA) for DATROWAY (datopotamab deruxtecan‑dlnk) and granted Priority Review for adults with unresectable or metastatic triple‑negative breast cancer (TNBC) who are not candidates for PD‑1/PD‑L1 inhibitor therapy. This filing is based on TROPION‑Breast02, where DATROWAY significantly improved overall survival versus chemotherapy; if approved, it could become the standard of care for this patient group. The FDA action (PDUFA) date is June 2, 2026.
DATROWAY is a TROP2‑directed DXd antibody‑drug conjugate discovered by Daiichi Sankyo and co‑developed with AstraZeneca. The sBLA is being reviewed under Project Orbis to allow concurrent international assessment. TROPION‑Breast02’s dual primary endpoints are progression‑free survival (by blinded independent review) and overall survival, with secondary measures including response rates, duration of response, pharmacokinetics, and safety. Additional global regulatory submissions for DATROWAY in breast and lung cancers are underway.
Read Announcement- Drug:
- datopotamab deruxtecan-dlnk
- Announced Date:
- June 24, 2025
- Indication:
- For patients with previously treated metastatic HR-positive, HER2-negative breast cancer
Announcement
AstraZeneca and Daiichi Sankyo announced that DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
AI Summary
AstraZeneca and Daiichi Sankyo announced that the US FDA has given accelerated approval for DATROWAY® (datopotamab deruxtecan-dlnk). This new treatment option is approved for adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have already received prior EGFR-directed therapy and platinum-based chemotherapy. The approval is based on the observed objective response rate and duration of response, with continued approval dependent on further clinical benefit data from ongoing confirmatory trials.
Supported by favorable data from the TROPION-Lung05 Phase II trial and the Phase III TROPION-Lung01 trial, DATROWAY is the first TROP2-directed therapy available in the US for lung cancer. This milestone provides patients with advanced EGFR-mutated NSCLC a promising new option, addressing the limited treatment choices available to those with resistant disease.
Read Announcement- Drug:
- datopotamab deruxtecan-dlnk
- Announced Date:
- January 17, 2025
- Indication:
- For patients with previously treated metastatic HR-positive, HER2-negative breast cancer
Announcement
AstraZeneca announced that DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
AI Summary
AstraZeneca recently announced the U.S. approval of DATROWAY® (datopotamab deruxtecan-dlnk) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer. This approval is specifically for patients who have already received endocrine-based therapy and chemotherapy for their advanced disease. The newly approved therapy targets TROP2, using Daiichi Sankyo’s established DXd ADC technology, and provides a promising alternative to conventional chemotherapy.
Based on data from the TROPION-Breast01 phase 3 trial, DATROWAY has shown significant benefits in reducing the risk of disease progression or death. This advancement marks an important step forward in treatment options for patients with HR-positive, HER2-negative metastatic breast cancer, potentially offering improved outcomes and a novel approach to combat the disease.
Read Announcement
NeXT Personal FDA Regulatory Events
NeXT Personal is a drug developed by Astrazeneca for the following indication: in patients with unresectable stage III, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NeXT Personal
- Announced Date:
- February 2, 2026
- Indication:
- in patients with unresectable stage III, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).
Announcement
Personalis, Inc. announced the publication of a new study in npj Precision Oncology highlighting the power of its ultrasensitive molecular residual disease (MRD) assay, NeXT Personal®, in monitoring immunotherapy response across a broad range of advanced cancers.
AI Summary
Personalis, Inc. announced a new study in npj Precision Oncology showing its ultrasensitive molecular residual disease (MRD) assay, NeXT Personal®, can monitor immunotherapy response across many advanced cancers. The study, led by researchers at UC San Diego Moores Cancer Center, looked at 39 patients with advanced solid tumors spanning nine cancer types who were treated with immune checkpoint inhibitors alone or with other therapies. The report notes that only about 10–40% of patients get lasting benefit from immunotherapy, so better tools to track response are needed.
The interim analysis found that ctDNA-based MRD monitoring with NeXT Personal revealed early predictors of who was responding to treatment. By detecting molecular signs of response or resistance sooner, the assay could help clinicians make timelier treatment decisions for patients with advanced cancer. The findings come from an ongoing study and suggest broad utility for ultrasensitive ctDNA monitoring in immunotherapy care.
Read Announcement- Drug:
- NeXT Personal
- Announced Date:
- October 16, 2025
- Indication:
- in patients with unresectable stage III, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).
Announcement
Personalis, Inc. announced new data from an AstraZeneca phase 3 clinical trial in lung cancer (LAURA).
Read Announcement
Datopotamab deruxtecan (Dato-DXd) FDA Regulatory Timeline and Events
Datopotamab deruxtecan (Dato-DXd) is a drug developed by Astrazeneca for the following indication: Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Datopotamab deruxtecan (Dato-DXd)
- Announced Date:
- January 13, 2026
- Indication:
- Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Announcement
Daiichi Sankyo and AstraZeneca announced that The first patient has been dosed in the TROPION-Lung17 phase 3 trial evaluating DATROWAY® (datopotamab deruxtecan) compared to docetaxel in patients with TROP2 NMR positive locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) without actionable genomic alterations previously treated with immunotherapy and platinum-based chemotherapy.
AI Summary
Daiichi Sankyo and AstraZeneca announced the first patient has been dosed in TROPION-Lung17, a global phase 3 trial comparing DATROWAY® (datopotamab deruxtecan) to docetaxel in people with TROP2 NMR–positive, locally advanced or metastatic nonsquamous non‑small cell lung cancer (NSCLC). Eligible patients must have no actionable genomic alterations and have previously received a PD‑1/PD‑L1 inhibitor and platinum‑based chemotherapy. DATROWAY is a TROP2‑directed antibody‑drug conjugate designed to deliver a chemotherapy payload to TROP2‑expressing tumor cells.
TROPION‑Lung17 will prospectively screen tumors for TROP2 NMR, a novel computational pathology measure meant to identify patients most likely to benefit. About 400 patients will be randomized 1:1 to DATROWAY (6 mg/kg) or docetaxel. The trial’s dual primary endpoints are progression‑free survival by blinded central review and overall survival, with key secondary measures including response rate and duration of response. Sites are planned across Asia, Europe and North America.
Read Announcement- Drug:
- Datopotamab deruxtecan (Dato-DXd)
- Announced Date:
- October 19, 2025
- Indication:
- Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Announcement
Daiichi Sankyo and AstraZeneca announced Positive results from the TROPION-Breast02 phase 3 trial showed DATROWAY®(datopotamab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator's choice of chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy was not an option.
AI Summary
Researchers from Daiichi Sankyo and AstraZeneca announced positive findings from the global Phase III TROPION-Breast02 trial of DATROWAY® in first-line treatment for locally recurrent inoperable or metastatic triple-negative breast cancer patients who cannot use immunotherapy.
DATROWAY, a TROP2-directed antibody-drug conjugate, significantly improved overall survival by 5 months compared to investigator’s choice chemotherapy (median 23.7 vs 18.7 months; hazard ratio [HR] 0.79; p=0.0291).
It cut the risk of disease progression or death by 43% (HR 0.57; p<0.0001), nearly doubling progression-free survival to 10.8 months versus 5.6 months, as assessed by blinded independent central review.
DATROWAY is the first therapy in this setting to show both survival and progression benefits over chemotherapy. Presented at the 2025 ESMO Congress, these results support DATROWAY as a new first-line option for metastatic triple-negative breast cancer patients not eligible for immunotherapy.
Read Announcement- Drug:
- Datopotamab deruxtecan (Dato-DXd)
- Announced Date:
- October 6, 2025
- Indication:
- Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Announcement
AstraZeneca and Daiichi Sankyo announced Positive high-level results from the TROPION-Breast02 Phase III trial showed Datroway (datopotamab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator's choice of chemotherapy as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option.
Read Announcement- Drug:
- Datopotamab deruxtecan (Dato-DXd)
- Announced Date:
- January 31, 2025
- Indication:
- Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Announcement
Daiichi Sankyo and AstraZeneca announced that The first patient has been dosed in the TROPION-Lung12 phase 3 trial evaluating the efficacy and safety of adjuvant DATROWAY® (datopotamab deruxtecan) plus rilvegostomig or rilvegostomig monotherapy versus standard of care in patients with stage 1 adenocarcinoma non-small cell lung cancer (NSCLC) after complete surgical resection who are ctDNA-positive or have other high risk pathological features.
AI Summary
Daiichi Sankyo and AstraZeneca have started dosing the first patient in the global TROPION-Lung12 Phase 3 trial. This study will evaluate the safety and efficacy of adjuvant DATROWAY® (datopotamab deruxtecan) combined with rilvegostomig, as well as rilvegostomig alone, compared to the current standard of care. The trial targets patients with stage 1 adenocarcinoma non-small cell lung cancer who are ctDNA-positive or have other high risk pathological features after complete surgical resection. By using a novel strategy that includes ctDNA screening, the study aims to better identify patients who could benefit from additional treatment. Researchers hope that combining the TROP2-directed ADC DATROWAY with immunotherapy will offer a new approach to reduce the high risk of disease recurrence seen in some early-stage lung cancer patients.
Read Announcement- Drug:
- Datopotamab deruxtecan (Dato-DXd)
- Announced Date:
- January 13, 2025
- Indication:
- Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Announcement
Daiichi Sankyo and AstraZeneca's Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy.
AI Summary
Daiichi Sankyo and AstraZeneca have received an important boost for their cancer treatment program. The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd). This therapy is aimed at treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that carries an epidermal growth factor receptor mutation and has progressed after prior systemic treatments, including EGFR-directed therapies. The FDA’s Priority Review designation highlights the potential of Dato-DXd to offer significant improvements over current treatment options. This decision is based on promising results from the phase 2 TROPION-Lung05 trial, as well as supportive data from earlier phase 1 and phase 3 studies. A regulatory decision is anticipated by July 12, 2025, marking a hopeful advancement for patients with advanced EGFR-mutated NSCLC.
Read Announcement- Drug:
- Datopotamab deruxtecan (Dato-DXd)
- Announced Date:
- December 9, 2024
- Indication:
- Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Announcement
Daiichi Sankyo and AstraZeneca announced that Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) with disease progression on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
AI Summary
Daiichi Sankyo and AstraZeneca announced that their investigational medicine, datopotamab deruxtecan (Dato-DXd), has been granted Breakthrough Therapy Designation (BTD) in the U.S. by the FDA. This designation targets adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that carries EGFR mutations, particularly those who have experienced disease progression after treatment with EGFR tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy.
The BTD status aims to accelerate the drug’s development and regulatory review, offering hope to patients facing limited treatment options. The decision was supported by data from the TROPION-Lung05 phase 2 trial and additional findings from the TROPION-Lung01 phase 3 trial, indicating promising improvements in treatment outcomes for patients with this serious form of lung cancer.
Read Announcement- Drug:
- Datopotamab deruxtecan (Dato-DXd)
- Announced Date:
- December 5, 2024
- Indication:
- Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Announcement
AstraZeneca announced that A pooled analysis of the TROPION-Lung05 phase 2 and the TROPION-Lung01 phase 3 trials showed datopotamab deruxtecan (Dato-DXd) demonstrated clinically meaningful tumor response in patients with previously treated advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
AI Summary
AstraZeneca announced promising results for datopotamab deruxtecan (Dato-DXd) in patients with previously treated advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). A pooled analysis from two clinical trials, TROPION-Lung05 (phase 2) and TROPION-Lung01 (phase 3), showed a confirmed overall response rate of 42.7% among 117 patients. These encouraging findings include 4.3% complete responses and 38.5% partial responses, indicating significant tumor shrinkage in a group of patients whose disease had progressed after previous treatments.
The analysis also reported a median duration of response of 7.0 months, along with meaningful progression-free and overall survival outcomes. AstraZeneca’s announcement highlights the potential of Dato-DXd to offer a new treatment option for patients with EGFR-mutated NSCLC who have exhausted other therapies.
Read Announcement- Drug:
- Datopotamab deruxtecan (Dato-DXd)
- Announced Date:
- September 23, 2024
- Indication:
- Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Announcement
AstraZeneca announced the Topline results from the TROPION-Breast01 phase 3 trial of datopotamab deruxtecan (Dato-DXd) compared to investigator's choice of chemotherapy, which previously met the dual primary endpoint of progression-free survival (PFS), did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metastatic hormone receptor (HR) positive, HER2 low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.
AI Summary
AstraZeneca announced top-line results from the TROPION-Breast01 phase 3 trial comparing datopotamab deruxtecan (Dato-DXd) with the investigator’s choice of chemotherapy. The study focused on patients with inoperable or metastatic hormone receptor–positive, HER2 low or negative breast cancer who had already been treated with endocrine therapy and at least one systemic treatment.
Although the trial previously met its dual primary endpoint by showing a significant improvement in progression-free survival, the final overall survival analysis did not achieve statistical significance. These findings underscore the challenge of improving long-term survival outcomes in advanced breast cancer. AstraZeneca plans to continue discussions with regulatory authorities and use these insights to advance its clinical development program for datopotamab deruxtecan.
Read Announcement- Drug:
- Datopotamab deruxtecan (Dato-DXd)
- Announced Date:
- September 8, 2024
- Indication:
- Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Announcement
AstraZeneca Results from an exploratory analysis of the TROPION-Lung01 phase 3 trial showed TROP2 as measured by quantitative continuous scoring (QCS), AstraZeneca's proprietary computational pathology platform, was predictive of clinical outcomes in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who were treated with datopotamab deruxtecan (Dato-DXd).
AI Summary
AstraZeneca recently presented exploratory results from the TROPION-Lung01 phase 3 trial at the IASLC 2024 World Conference on Lung Cancer. The study used a new computational pathology tool called Quantitative Continuous Scoring (QCS) to measure TROP2 levels in patients with advanced or metastatic non-small cell lung cancer who received datopotamab deruxtecan (Dato-DXd). Findings showed that patients with tumors testing positive for the TROP2-QCS biomarker experienced a notably greater benefit from the treatment than those who received docetaxel. Specifically, these patients had a 43% lower risk of disease progression or death, with longer progression-free survival observed. This analysis suggests that QCS may be a powerful tool to predict which patients can benefit most from Dato-DXd, helping guide more personalized treatment decisions in lung cancer care.
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Enhertu (Trastuzumab deruxtecan) FDA Regulatory Timeline and Events
Enhertu (Trastuzumab deruxtecan) is a drug developed by Astrazeneca for the following indication: Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Enhertu (Trastuzumab deruxtecan)
- Announced Date:
- December 22, 2025
- Indication:
- Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)
Announcement
Daiichi Sankyo and AstraZeneca announced that
AI Summary
Daiichi Sankyo and AstraZeneca announced that the first patient has been dosed in DESTINY‑Endometrial02, a global phase 3 trial testing ENHERTU (trastuzumab deruxtecan) as an adjuvant treatment after surgery for HER2‑expressing (IHC 3+/2+) endometrial cancer. The study will compare ENHERTU, with or without radiotherapy, to standard chemotherapy (carboplatin and paclitaxel), with or without radiotherapy. The trial is run in partnership with The GOG Foundation and the European ENGOT network, with GINECO leading ENGOT sites.
ENHERTU is an antibody‑drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca. DESTINY‑Endometrial02 will enroll about 710 patients across Asia, Europe, North and South America. The main goal is to see if ENHERTU can improve disease‑free survival, with overall survival a key secondary endpoint. This is the first phase 3 study to test a HER2‑directed therapy in the adjuvant setting for HER2‑expressing endometrial cancer.
Read Announcement- Drug:
- Enhertu (Trastuzumab deruxtecan)
- Announced Date:
- December 9, 2025
- Indication:
- Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)
Announcement
AstraZenca announced that The first patient has been dosed in the randomization phase of the DESTINY-Ovarian01 phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy in patients with HER2 expressing (IHC 3+/2+/1+) advanced high-grade epithelial ovarian cancer following treatment with first-line platinum-based chemotherapy in combination with bevacizumab.
AI Summary
AstraZeneca announced the first patient has been dosed in the randomization phase of DESTINY‑Ovarian01, a global phase 3 trial testing ENHERTU (trastuzumab deruxtecan) plus bevacizumab versus bevacizumab alone as first‑line maintenance therapy. The study enrolls patients with HER2‑expressing (IHC 3+/2+/1+) advanced high‑grade epithelial ovarian cancer after they complete first‑line platinum‑based chemotherapy combined with bevacizumab. A non‑randomized safety run‑in evaluated the combination before the randomized stage. ENHERTU is a HER2‑directed DXd antibody‑drug conjugate discovered by Daiichi Sankyo and jointly developed with AstraZeneca.
The trial’s primary endpoint is progression‑free survival assessed by blinded independent central review in the HER2 IHC 3+/2+ group, with overall survival as a key secondary endpoint. DESTINY‑Ovarian01 plans to enroll about 580 patients across Asia, Europe, North and South America and is run in collaboration with ENGOT (led by GEICO), GOG‑F, and APGOT. The study aims to see if adding ENHERTU to bevacizumab can offer a new maintenance option for patients, addressing an unmet need given HER2 expression in many ovarian cancers.
Read Announcement- Drug:
- Enhertu (Trastuzumab deruxtecan)
- Announced Date:
- October 18, 2025
- Indication:
- Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)
Announcement
Daiichi Sankyo and AstraZeneca announced Positive results from the DESTINY-Breast11 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) in the neoadjuvant setting (before surgery) demonstrated a statistically significant and clinically meaningful improvement in the pathologic complete response (pCR) rate when compared with dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP) in patients with high-risk, locally advanced HER2 positive early-stage breast cancer.
AI Summary
Daiichi Sankyo and AstraZeneca announced positive results from the DESTINY-Breast11 phase 3 trial, showing that neoadjuvant treatment with ENHERTU (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) significantly improved outcomes in high-risk, locally advanced HER2-positive early breast cancer.
In the study, patients receiving ENHERTU plus THP achieved a pathologic complete response (pCR) rate of 67.3% versus 56.3% with standard dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP), marking an 11.2% absolute improvement (p=0.003). This benefit appeared in both hormone receptor–positive and –negative subgroups.
After surgery, 81.3% of patients in the ENHERTU arm had no or minimal residual invasive cancer, compared with 69.1% in the comparator group. An early event-free survival analysis also trended in favor of ENHERTU plus THP.
The safety profile was favorable, with lower rates of grade 3+ adverse events (37.5% vs 55.8%), serious AEs, treatment interruptions and left ventricular dysfunction, with no new concerns identified. These data support ENHERTU plus THP as a potential new standard in the neoadjuvant setting.
Read Announcement- Drug:
- Enhertu (Trastuzumab deruxtecan)
- Announced Date:
- September 29, 2025
- Indication:
- Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)
Announcement
AstraZeneca announced Positive high-level results from a planned interim analysis of the DESTINY-Breast05 Phase III trial showed Enhertu (trastuzumab deruxtecan) demonstrated a highly statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive early breast cancer with residual invasive disease in the breast or axillary lymph nodes after neoadjuvant treatment and a high risk of disease recurrence.
Read Announcement- Drug:
- Enhertu (Trastuzumab deruxtecan)
- Announced Date:
- June 9, 2025
- Indication:
- Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)
Announcement
Daiichi Sankyo and AstraZeneca announced that The first patient has been dosed in the DESTINY-Endometrial01 phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) in combination with rilvegostomig or pembrolizumab versus platinum-based chemotherapy (carboplatin and paclitaxel) in combination with pembrolizumab as a first-line therapy in patients with HER2 expressing (IHC 3+/ 2+), mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer.
AI Summary
Daiichi Sankyo and AstraZeneca have announced that the first patient has been dosed in the DESTINY‐Endometrial01 phase 3 clinical trial. This study is designed to evaluate ENHERTU® (trastuzumab deruxtecan) in combination with either rilvegostomig or pembrolizumab against the standard treatment of platinum-based chemotherapy (carboplatin and paclitaxel) plus pembrolizumab. The trial will focus on patients receiving first-line therapy for advanced or recurrent endometrial cancer whose tumors express HER2 (IHC 3+ or 2+) and are mismatch repair proficient (pMMR). With a global enrollment target of approximately 600 patients, the study aims to improve outcomes in a cancer setting where median overall survival is up to 30 months. This trial is being conducted collaboratively with The GOG Foundation and the European Network of Gynecological Oncological Trial (ENGOT).
Read Announcement- Drug:
- Enhertu (Trastuzumab deruxtecan)
- Announced Date:
- June 2, 2025
- Indication:
- Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)
Announcement
Daiichi Sankyo and AstraZeneca announced Positive results from the DESTINY-Breast09 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment in patients with HER2 positive metastatic breast cancer. Results will be presented today during a special late-breaking oral session (LBA #1008) at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting.
AI Summary
Daiichi Sankyo and AstraZeneca announced positive results from the DESTINY-Breast09 phase 3 trial, showing that the combination of ENHERTU® (trastuzumab deruxtecan) and pertuzumab significantly improves progression-free survival (PFS) in patients with HER2-positive metastatic breast cancer. The trial demonstrated a 44% reduction in the risk of disease progression or death compared to the standard treatment of taxane, trastuzumab, and pertuzumab (THP). The median PFS was 40.7 months with the ENHERTU combination versus 26.9 months with THP. These highly statistically significant and clinically meaningful results were consistent across various patient subgroups. The encouraging findings, suggesting a potential new first-line standard of care, will be presented during a special late-breaking oral session (LBA #1008) at the 2025 ASCO Annual Meeting.
Read Announcement- Drug:
- Enhertu (Trastuzumab deruxtecan)
- Announced Date:
- May 7, 2025
- Indication:
- Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)
Announcement
AstraZeneca announced that Positive topline results from the DESTINY-Breast11 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) rate versus standard of care (dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP]) when used in the neoadjuvant setting (before surgery) in patients with high-risk, locally advanced HER2 positive early-stage breast cancer.
AI Summary
AstraZeneca announced positive topline results from the DESTINY-Breast11 phase 3 trial. In this study, patients with high‐risk, locally advanced HER2-positive early-stage breast cancer who received ENHERTU (trastuzumab deruxtecan) followed by a combination of paclitaxel, trastuzumab, and pertuzumab (THP) showed a statistically significant and clinically meaningful improvement in the pathologic complete response (pCR) rate compared to the standard of care. The standard treatment, which includes dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP), typically challenges patients due to its intensity and side effects. The improved pCR rate is an important outcome since achieving pCR is associated with better long-term survival prospects. These promising results may pave the way for a new neoadjuvant treatment option for patients with aggressive early-stage HER2-positive breast cancer.
Read Announcement- Drug:
- Enhertu (Trastuzumab deruxtecan)
- Announced Date:
- March 31, 2025
- Indication:
- Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)
Announcement
AstraZeneca announced that The first patient has been dosed in the DESTINY-Gastric05 phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) in combination with a fluoropyrimidine chemotherapy (5-FU or capecitabine)
AI Summary
AstraZeneca announced that the first patient has been dosed in the DESTINY-Gastric05 phase 3 trial. This study will evaluate ENHERTU® (trastuzumab deruxtecan) in combination with a fluoropyrimidine chemotherapy (either 5-FU or capecitabine) and KEYTRUDA® (pembrolizumab) against a regimen that includes trastuzumab with platinum-based chemotherapy and pembrolizumab. The trial is designed for previously untreated patients with unresectable, locally advanced, or metastatic HER2 positive gastric or gastroesophageal junction cancer with a PD-L1 CPS of 1 or greater.
By assessing progression-free survival and overall survival, the trial aims to determine whether this innovative, potentially platinum-free treatment approach can improve outcomes. An exploratory cohort will include patients with lower PD-L1 expression to further understand the benefits of combining ENHERTU with immunotherapy and chemotherapy in diverse patient populations.
Read Announcement- Drug:
- Enhertu (Trastuzumab deruxtecan)
- Announced Date:
- March 3, 2025
- Indication:
- Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)
Announcement
Daiichi Sankyo and AstraZeneca announced Positive topline results from the DESTINY-Gastric04 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) compared to ramucirumab and paclitaxel in patients with second-line HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
AI Summary
Daiichi Sankyo and AstraZeneca announced encouraging phase 3 trial results from DESTINY-Gastric04. The study showed that ENHERTU (trastuzumab deruxtecan) significantly improved overall survival compared to the combination of ramucirumab and paclitaxel in patients with unresectable and/or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction adenocarcinoma who are receiving second-line treatment. This finding marks a breakthrough, as ENHERTU becomes the first HER2-directed therapy to show a meaningful survival benefit in this setting.
Based on its strong performance, the Independent Data Monitoring Committee recommended unblinding the trial. Daiichi Sankyo and AstraZeneca now plan to work with regulatory authorities around the world to expand the use of ENHERTU, potentially offering new hope and extended survival for patients battling advanced gastric cancer.
Read Announcement- Drug:
- Enhertu (Trastuzumab deruxtecan)
- Announced Date:
- August 13, 2024
- Indication:
- Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)
Announcement
AstraZeneca and Daiichi Sankyo announced that Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received two or more prior treatment regimens.
Read Announcement
ENHERTU® (fam-trastuzumab deruxtecan-nxki) FDA Regulatory Timeline and Events
ENHERTU® (fam-trastuzumab deruxtecan-nxki) is a drug developed by Astrazeneca for the following indication: For the treatment of adult patients with unresectable or metastatic HER2 positive.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ENHERTU® (fam-trastuzumab deruxtecan-nxki)
- Announced Date:
- December 22, 2025
- Indication:
- For the treatment of adult patients with unresectable or metastatic HER2 positive
Announcement
AstraZeneca and Daiichi Sankyo's ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the US for adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.
AI Summary
AstraZeneca and Daiichi Sankyo announced that ENHERTU® (fam‑trastuzumab deruxtecan‑nxki) has received Breakthrough Therapy Designation (BTD) from the U.S. FDA for adults with HER2‑positive early breast cancer who have residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and are at high risk of recurrence. The BTD is designed to speed development and regulatory review of therapies that address serious conditions and unmet medical needs.
The decision was based on results from the DESTINY‑Breast05 Phase III trial, presented at the 2025 ESMO Congress and published in The New England Journal of Medicine. DESTINY‑Breast05 randomized 1,635 patients with high‑risk residual disease (including those who were inoperable before neoadjuvant therapy or had pathologically positive nodes after it) and used invasive disease‑free survival as the primary endpoint. The companies say the data show ENHERTU reduced invasive recurrence versus the current standard and could help more patients reach a cure; they will now work with the FDA on its post‑neoadjuvant use.
Read Announcement- Drug:
- ENHERTU® (fam-trastuzumab deruxtecan-nxki)
- Announced Date:
- October 18, 2025
- Indication:
- For the treatment of adult patients with unresectable or metastatic HER2 positive
Announcement
Daiichi Sankyo and AstraZeneca announced Positive results from the DESTINY-Breast11 Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) followed by paclitaxel, trastuzumab and pertuzumab (THP) in the neoadjuvant setting (before surgery) demonstrated a statistically significant and clinically meaningful improvement in the pathologic complete response (pCR) rate.
AI Summary
Daiichi Sankyo and AstraZeneca reported positive results from the DESTINY-Breast11 Phase III trial in patients with high-risk, HER2-positive early breast cancer. In the neoadjuvant setting, four cycles of ENHERTU® (fam-trastuzumab deruxtecan-nxki) followed by four cycles of paclitaxel, trastuzumab and pertuzumab (THP) achieved a pathologic complete response (pCR) rate of 67.3%, compared with 56.3% for the standard dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP), a statistically significant 11.2% improvement (p=0.003).
Improvements were seen in both hormone receptor–positive (61.4% vs 52.3%) and hormone receptor–negative (83.1% vs 67.1%) subgroups. Additionally, 81.3% of patients in the ENHERTU-THP arm had no or minimal residual invasive cancer (RCB 0+I) after surgery, versus 69.1% with ddAC-THP.
The safety profile of ENHERTU-THP was favorable, with lower rates of Grade 3 or higher adverse events (37.5% vs 55.8%), serious adverse events (10.6% vs 20.2%), treatment interruptions (37.8% vs 54.5%) and left ventricular dysfunction (1.3% vs 6.1%), while interstitial lung disease rates remained low and similar between arms.
Read Announcement- Drug:
- ENHERTU® (fam-trastuzumab deruxtecan-nxki)
- Announced Date:
- October 1, 2025
- Indication:
- For the treatment of adult patients with unresectable or metastatic HER2 positive
Announcement
Daiichi Sankyo and AstraZeneca announced that the supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) followed by paclitaxel, trastuzumab and pertuzumab (THP) has been accepted for review in the U.S. for the neoadjuvant treatment of adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer.
AI Summary
Daiichi Sankyo and AstraZeneca announced that the FDA has accepted their supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) followed by paclitaxel, trastuzumab and pertuzumab (THP) for review. The application seeks approval for neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) stage 2 or 3 breast cancer.
Acceptance is based on DESTINY-Breast11, a global phase 3 trial showing that ENHERTU followed by THP significantly improved pathologic complete response (pCR) rates and offered a favorable safety profile compared to dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP). The study also demonstrated an early positive trend in event-free survival (EFS). Under the Prescription Drug User Fee Act (PDUFA), the FDA’s target action date is May 18, 2026.
ENHERTU is a HER2-directed DXd antibody–drug conjugate discovered by Daiichi Sankyo and co-developed with AstraZeneca. If approved, this regimen could become a new pre-surgery treatment option for patients with high-risk, locally advanced HER2-positive early-stage breast cancer.
Read Announcement- Drug:
- ENHERTU® (fam-trastuzumab deruxtecan-nxki)
- Announced Date:
- September 24, 2025
- Indication:
- For the treatment of adult patients with unresectable or metastatic HER2 positive
Announcement
AstraZeneca and Daiichi Sankyo announced that supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been accepted and granted Priority Review in the U.S. for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer.
AI Summary
AstraZeneca and Daiichi Sankyo announced that the U.S. Food and Drug Administration has accepted and granted Priority Review to their supplemental Biologics License Application for ENHERTU® (fam-trastuzumab deruxtecan-nxki) used with pertuzumab. This filing seeks approval for first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer and is being reviewed under the FDA’s Real-Time Oncology Review program, with a decision target date of January 23, 2026.
In the global DESTINY-Breast09 phase 3 trial, ENHERTU plus pertuzumab reduced the risk of disease progression or death by 44% compared to the standard taxane, trastuzumab and pertuzumab regimen. The combination achieved a median progression-free survival of 40.7 months—over three years—versus 26.9 months with the standard treatment.
If approved, this HER2-directed antibody-drug conjugate approach would enter the first-line metastatic setting and has the potential to become a new standard of care for patients with HER2-positive metastatic breast cancer.
Read Announcement- Drug:
- ENHERTU® (fam-trastuzumab deruxtecan-nxki)
- Announced Date:
- June 2, 2025
- Indication:
- For the treatment of adult patients with unresectable or metastatic HER2 positive
Announcement
AstraZeneca and Daiichi Sankyo announced Positive results from the DESTINY-Breast09 Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to a taxane, trastuzumab and pertuzumab (THP) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer.
AI Summary
AstraZeneca and Daiichi Sankyo announced positive results from the DESTINY-Breast09 Phase III trial. The study showed that combining ENHERTU® (fam-trastuzumab deruxtecan‑nxki) with pertuzumab significantly improved progression‑free survival (PFS) compared to the standard first‑line treatment (a taxane with trastuzumab and pertuzumab, THP) for patients with HER2‑positive metastatic breast cancer.
The trial demonstrated that the combination reduced the risk of disease progression or death by 44%, with a median PFS of 40.7 months versus 26.9 months for the THP group. This highly statistically significant and clinically meaningful improvement suggests that starting treatment with ENHERTU plus pertuzumab may offer patients a longer period without disease progression compared to current standard care.
Read Announcement- Drug:
- ENHERTU® (fam-trastuzumab deruxtecan-nxki)
- Announced Date:
- April 21, 2025
- Indication:
- For the treatment of adult patients with unresectable or metastatic HER2 positive
Announcement
AstraZeneca and Daiichi Sankyo announces Positive high-level results from a planned interim analysis of the DESTINY-Breast09 Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to a taxane, trastuzumab and pertuzumab (THP) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer.
AI Summary
AstraZeneca and Daiichi Sankyo announced positive high-level results from the DESTINY-Breast09 Phase III trial. In a planned interim analysis, the combination of ENHERTU (fam-trastuzumab deruxtecan-nxki) with pertuzumab showed a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to the first-line standard therapy of taxane, trastuzumab, and pertuzumab (THP) in patients with HER2-positive metastatic breast cancer. This benefit was consistent across all pre-specified patient subgroups.
The interim analysis also showed an early trend towards improved overall survival. These results mark the first breakthrough in more than a decade that demonstrates superior efficacy versus the established THP regimen, supporting the potential of ENHERTU in combination with pertuzumab as a new valuable treatment option for patients with aggressive HER2-positive metastatic breast cancer.
Read Announcement- Drug:
- ENHERTU® (fam-trastuzumab deruxtecan-nxki)
- Announced Date:
- January 27, 2025
- Indication:
- For the treatment of adult patients with unresectable or metastatic HER2 positive
Announcement
AstraZeneca and Daiichi Sankyo announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a Food and Drug Administration (FDA)-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
AI Summary
AstraZeneca and Daiichi Sankyo announced that the FDA has approved ENHERTU® (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HR‐positive breast cancer whose tumors are HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining). This approval applies to patients whose disease has progressed after one or more endocrine therapies, based on results from the DESTINY-Breast06 Phase III trial.
The trial demonstrated that ENHERTU improved outcomes, with patients experiencing a median progression-free survival of over one year compared to chemotherapy. The FDA granted Priority Review and Breakthrough Therapy Designation for this indication, expanding the use of HER2-directed therapy to a broader group of patients and potentially setting a new standard care for those with HR-positive, HER2-expressing metastatic breast cancer.
Read Announcement- Drug:
- ENHERTU® (fam-trastuzumab deruxtecan-nxki)
- Announced Date:
- October 1, 2024
- Indication:
- For the treatment of adult patients with unresectable or metastatic HER2 positive
Announcement
AstraZeneca and Daiichi Sankyo announced that the supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting.
AI Summary
AstraZeneca and Daiichi Sankyo announced that the supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan‑nxki) has been accepted by the FDA and granted Priority Review. This decision speeds up the review process for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH‑) or HER2 ultralow (IHC 0 with membrane staining) breast cancer who have previously received at least one endocrine therapy in the metastatic setting.
If approved, ENHERTU would become the first HER2-directed therapy and antibody drug conjugate available for patients before they receive chemotherapy, potentially offering a significant new treatment option. The FDA’s Priority Review designation, with a PDUFA action date set for February 1, 2025, highlights the promise of this therapy in filling an unmet need for these breast cancer patients.
Read Announcement- Drug:
- ENHERTU® (fam-trastuzumab deruxtecan-nxki)
- Announced Date:
- August 19, 2024
- Indication:
- For the treatment of adult patients with unresectable or metastatic HER2 positive
Announcement
AstraZeneca and Daiichi Sankyo announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of unresectable or metastatic hormone receptor positive HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC >0 <1+) breast cancer patients who have received either two lines of endocrine therapy in the metastatic setting, or one line of endocrine therapy if they had demonstrated disease progression within six months of starting first-line treatment with endocrine therapy in combination with a CDK4/6 inhibitor or within 24 months of the start of adjuvant endocrine therapy.
AI Summary
AstraZeneca and Daiichi Sankyo announced that their HER2-directed antibody drug conjugate, ENHERTU®, has received Breakthrough Therapy Designation (BTD) from the FDA. This designation is based on promising results from the DESTINY-Breast06 phase 3 trial. It targets patients with unresectable or metastatic hormone receptor–positive breast cancer that is either HER2 low (IHC 1+ or IHC 2+/ISH–) or HER2 ultralow (IHC >0 but <1+). Eligible patients include those who have received two lines of endocrine therapy in the metastatic setting or one line if rapid disease progression occurred within six months of starting combined endocrine therapy with a CDK4/6 inhibitor or within 24 months of beginning adjuvant treatment. The BTD is intended to speed up the development and review of therapies that address serious conditions with significant unmet medical needs, potentially expanding treatment options for these patients.
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CALQUENCE FDA Regulatory Timeline and Events
CALQUENCE is a drug developed by Astrazeneca for the following indication: In patients with treatment-naïve CLL.1.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CALQUENCE
- Announced Date:
- December 4, 2025
- Indication:
- In patients with treatment-naïve CLL.1
Announcement
AstraZeneca advances its ambition to redefine hematology care with new data from its diverse pipeline and portfolio at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6-9, 2025.
AI Summary
AstraZeneca is advancing its ambition to redefine hematology care with new data presented at the 67th American Society of Hematology (ASH) Annual Meeting, December 6–9, 2025. The company is mounting its largest ASH presence to date with 65 abstracts across eight approved and investigational medicines, including 15 oral presentations. Key early results highlight surovatamig, a CD19xCD3 T‑cell engager, showing updated three‑year follow‑up activity in relapsed/refractory follicular lymphoma and responses in other B‑cell cancers, and AZD0120, a dual BCMA/CD19 CAR T therapy, with initial safety and efficacy signals in relapsed/refractory multiple myeloma.
Approved medicines are also featured: new CALQUENCE data in mantle cell lymphoma and chronic lymphocytic leukemia and additional ULTOMIRIS results supporting benefits in paroxysmal nocturnal hemoglobinuria and pediatric HSCT‑TMA. AstraZeneca emphasizes a broad approach—small molecules, complement inhibitors and cell therapies—aimed at improving outcomes across malignant and rare hematologic diseases. The presentations are intended to show early clinical promise and safety across this diverse pipeline.
Read Announcement- Drug:
- CALQUENCE
- Announced Date:
- May 6, 2025
- Indication:
- In patients with treatment-naïve CLL.1
Announcement
PUBLISHED 6 May 2025 Approval based on ECHO Phase III trial results which demonstrated over 16 months of progression-free survival improvement vs. chemoimmunotherapy alone AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the European Union (EU) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant.
Read Announcement- Drug:
- CALQUENCE
- Announced Date:
- January 17, 2025
- Indication:
- In patients with treatment-naïve CLL.1
Announcement
AstraZeneca announced that CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation.
AI Summary
AstraZeneca announced that the FDA has approved CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab for adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. This marks the first and only BTK inhibitor approved for first-line treatment of MCL in the US.
The approval was granted under Priority Review, based on the ECHO Phase III trial results that showed more than 16 months of progression-free survival improvement compared to chemoimmunotherapy alone. MCL is a rare and aggressive form of non-Hodgkin lymphoma, and this new treatment option offers a promising alternative for patients who cannot undergo intensive transplant procedures. The breakthrough is expected to benefit patients by providing a more effective, tolerable therapy option early in the treatment process.
Read Announcement- Drug:
- CALQUENCE
- Announced Date:
- December 8, 2024
- Indication:
- In patients with treatment-naïve CLL.1
Announcement
AstraZeneca announced Positive results from the AMPLIFY Phase III trial showed AstraZeneca's CALQUENCE®(acalabrutinib) in combination with venetoclax demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukemia (CLL).
AI Summary
AstraZeneca announced positive results from the AMPLIFY Phase III trial for CALQUENCE® (acalabrutinib) used with venetoclax in treating previously untreated adult chronic lymphocytic leukemia (CLL). The trial found that this all-oral fixed-duration treatment significantly improved progression-free survival (PFS) compared to standard chemoimmunotherapy. Specifically, CALQUENCE plus venetoclax reduced the risk of disease progression or death by 35%, while the addition of obinutuzumab led to a 58% reduction. These results demonstrate promising clinical benefits and suggest CALQUENCE could become the first all-oral fixed-duration regimen combining a second-generation BTK inhibitor with venetoclax. The findings offer patients a treatment option that may reduce the duration of therapy and lower the risk of long-term side effects and drug resistance. Further data will be presented at the upcoming ASH 2024 Annual Meeting in San Diego, CA.
Read Announcement- Drug:
- CALQUENCE
- Announced Date:
- October 3, 2024
- Indication:
- In patients with treatment-naïve CLL.1
Announcement
AstraZeneca's supplemental New Drug Application (sNDA) for CALQUENCE® (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).
AI Summary
AstraZeneca’s supplemental New Drug Application (sNDA) for CALQUENCE® (acalabrutinib) has been accepted by the FDA and given Priority Review for treating adult patients with previously untreated mantle cell lymphoma (MCL). This designation is part of Project Orbis, an initiative that allows for concurrent international review of oncology treatments, and it could lead to faster regulatory decisions. The Priority Review status is granted when a new application shows the promise of significantly better safety or effectiveness compared to existing therapies. Data from the ECHO Phase III trial supports CALQUENCE by demonstrating that, when added to standard chemoimmunotherapy, the treatment lowers the risk of disease progression or death by 27%. The FDA’s review is expected to conclude in the first quarter of 2025, potentially offering a new therapeutic option for this challenging and aggressive type of non-Hodgkin lymphoma.
Read Announcement- Drug:
- CALQUENCE
- Announced Date:
- July 29, 2024
- Indication:
- In patients with treatment-naïve CLL.1
Announcement
Astrazeneca announced that Positive high-level results from an interim analysis of the AMPLIFY Phase III trial showed a fixed duration of AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukaemia (CLL).
Read Announcement- Drug:
- CALQUENCE
- Announced Date:
- June 16, 2024
- Indication:
- In patients with treatment-naïve CLL.1
Announcement
AstraZeneca announced that Positive results from the ECHO Phase III trial showed CALQUENCE®(acalabrutinib) in combination with bendamustine and rituximab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and showed a favorable trend in overall survival (OS) compared to standard-of-care chemoimmunotherapy (bendamustine plus rituximab) in previously untreated patients with mantle cell lymphoma (MCL).
AI Summary
AstraZeneca announced that the ECHO Phase III trial met its primary endpoint with CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab showing significant clinical benefits for patients with mantle cell lymphoma (MCL) who had not received previous treatment. The combination significantly improved progression‐free survival (PFS), reducing the risk of disease progression or death by 27% compared to standard chemoimmunotherapy. Median PFS reached 66.4 months versus 49.6 months with the standard treatment.
The trial also demonstrated a favorable trend in overall survival (OS) for patients receiving the CALQUENCE regimen, highlighting its potential as an effective first-line treatment option in MCL. These promising data suggest that adding CALQUENCE to the treatment plan can offer patients more time without disease progression and may help change the standard-of-care for this aggressive form of lymphoma.
Read Announcement
Baxdrostat FDA Regulatory Events
Baxdrostat is a drug developed by Astrazeneca for the following indication: For Patients With Hard-to-control Hypertension.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- baxdrostat
- Announced Date:
- December 2, 2025
- Indication:
- For Patients With Hard-to-control Hypertension
Announcement
AstraZeneca's New Drug Application (NDA) for baxdrostat has been accepted for Priority Review by the US Food and Drug Administration (FDA) in the US for the treatment of adult patients with hard-to-control (uncontrolled or treatment resistant) hypertension as an add-on to other antihypertensive medicines when these do not provide adequate lowering of blood pressure.
Read Announcement- Drug:
- baxdrostat
- Announced Date:
- December 2, 2025
- Indication:
- For Patients With Hard-to-control Hypertension
Announcement
AstraZeneca announced that The Prescription Drug User Fee Act (PDUFA) date is anticipated during the second quarter of 2026 following use of a Priority Review voucher.
Read Announcement
Selumetinib FDA Regulatory Events
Selumetinib is a drug developed by Astrazeneca for the following indication: for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibroma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- selumetinib
- Announced Date:
- November 20, 2025
- Indication:
- for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibroma
Announcement
Alexion, AstraZeneca Rare Disease’s Koselugo (selumetinib), an oral, selective MEK inhibitor, has been approved in the US for the treatment of adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).1
Read Announcement- Drug:
- selumetinib
- Announced Date:
- November 19, 2025
- Indication:
- for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibroma
Announcement
AstraZeneca Pharmaceuticals LP announced that the Food and Drug Administration approved selumetinib or adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
Read Announcement
Bax24 FDA Regulatory Events
Bax24 is a drug developed by Astrazeneca for the following indication: Patients with treatment-resistant hypertension (rHTN).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Bax24
- Announced Date:
- November 9, 2025
- Indication:
- Patients with treatment-resistant hypertension (rHTN)
Announcement
AstraZeneca announced Positive full results from the Bax24 Phase III trial showed baxdrostat demonstrated a statistically significant and highly clinically meaningful reduction in ambulatory 24-hour average systolic blood pressure (SBP) compared with placebo at 12 weeks.
AI Summary
AstraZeneca reported positive full results from the Bax24 Phase III trial showing that baxdrostat 2 mg, given once daily on top of standard care, produced a statistically significant and highly clinically meaningful fall in ambulatory 24‑hour average systolic blood pressure (SBP) versus placebo at 12 weeks. The placebo‑adjusted reduction in 24‑hour SBP was 14.0 mmHg (95% CI −17.2, −10.8; p<0.0001), with consistent effects across the full 24‑hour period, including the high‑risk early morning hours.
Key secondary findings included a 13.9 mmHg placebo‑adjusted drop in night‑time ambulatory SBP and a 10.3 mmHg reduction in seated SBP (both p<0.0001). Significantly more baxdrostat patients (71%) reached an ambulatory 24‑hour SBP under 130 mmHg versus 17% on placebo (odds ratio 15.2). Baxdrostat was generally well tolerated, with a safety profile consistent with prior trials.
The randomized, double‑blind Bax24 study enrolled patients with treatment‑resistant hypertension and the full results were presented at the AHA Scientific Sessions 2025. AstraZeneca plans to share the data with regulators worldwide.
Read Announcement- Drug:
- Bax24
- Announced Date:
- October 7, 2025
- Indication:
- Patients with treatment-resistant hypertension (rHTN)
Announcement
AstraZeneca announced Positive high-level results from the Bax24 Phase III trial showed baxdrostat demonstrated a statistically significant and highly clinically meaningful reduction in ambulatory 24-hour average systolic blood pressure (SBP) compared with placebo at 12 weeks. Efficacy was observed throughout the 24-hour period, including early morning, when patients with hypertension are at a higher risk of cardiovascular events.
Read Announcement
FASENRA FDA Regulatory Events
FASENRA is a drug developed by Astrazeneca for the following indication: For treatment of children aged 6 to 11 with severe asthma.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FASENRA
- Announced Date:
- November 7, 2025
- Indication:
- For treatment of children aged 6 to 11 with severe asthma
Announcement
AstraZeneca announced Positive full results from the NATRON Phase III trial showed AstraZeneca's FASENRA(benralizumab) demonstrated a statistically significant delay in the time to first worsening or flare in hypereosinophilic syndrome (HES),1 a rare disease driven by elevated eosinophils.2
AI Summary
AstraZeneca reported positive full results from the Phase III NATRON trial showing FASENRA (benralizumab) significantly delayed the time to first worsening or flare in hypereosinophilic syndrome (HES), a rare disease driven by high eosinophil levels. The trial met its primary endpoint, with FASENRA reducing the risk of HES worsening/flare by 65% versus placebo (19.4% vs 42.4%; hazard ratio 0.35; 95% CI 0.18–0.69; P=0.0024). These results will be presented at the ACAAI 2025 meeting.
Key secondary findings included fewer patients experiencing a flare or withdrawing (22.4% vs 45.5%; odds ratio 0.31; P=0.0033), a 66% reduction in annualized flare rate (0.41 vs 1.23; rate ratio 0.34; P=0.0008), and delayed hematologic relapse (HR 0.08; P<0.0001). FASENRA also showed greater fatigue relief with a single monthly dose versus placebo by Week 4, lasting through Week 24 (LS mean difference -4.72; P=0.0017). Safety matched the known profile of the medicine.
Read Announcement- Drug:
- FASENRA
- Announced Date:
- September 18, 2024
- Indication:
- For treatment of children aged 6 to 11 with severe asthma
Announcement
AstraZeneca announced that FASENRA® (benralizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).1 EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal
AI Summary
AstraZeneca’s FASENRA® (benralizumab) has been approved in the US to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare, immune-mediated vasculitis that can damage multiple organs and be fatal if left untreated. The approval followed positive results from the MANDARA Phase III trial, which showed that nearly 60% of FASENRA-treated patients achieved remission. Additionally, 41% of patients were able to fully taper off oral corticosteroids, reducing the risk of long-term side effects associated with steroid use.
This new approval gives patients with EGPA a much-needed treatment option. With a convenient once-monthly subcutaneous injection, FASENRA offers hope in effectively managing EGPA symptoms and preventing serious organ damage, marking an important milestone for patients facing this challenging condition.
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Tezepelumab-ekko FDA Regulatory Events
Tezepelumab-ekko is a drug developed by Astrazeneca for the following indication: For nasal polyp severity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- tezepelumab-ekko
- Announced Date:
- October 17, 2025
- Indication:
- For nasal polyp severity
Announcement
Amgen and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) approved TEZSPIRE® (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older.
AI Summary
Amgen and AstraZeneca announced that the U.S. Food and Drug Administration approved TEZSPIRE® (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older. TEZSPIRE is the first biologic targeting thymic stromal lymphopoietin (TSLP) for this disease.
CRSwNP affects about 320 million people worldwide, causing chronic inflammation, nasal blockage, and loss of smell. In the Phase III WAYPOINT trial, TEZSPIRE led to significant reductions in polyp size, nearly eliminated the need for surgery, and cut systemic corticosteroid use compared to placebo.
This approval gives patients a new treatment option that addresses the underlying inflammation driving CRSwNP. TEZSPIRE’s safety profile was consistent with earlier studies; the most common side effects were nasopharyngitis, upper respiratory tract infections, and mild injection-site reactions.
Read Announcement- Drug:
- tezepelumab-ekko
- Announced Date:
- March 1, 2025
- Indication:
- For nasal polyp severity
Announcement
AstraZeneca and Amgen' announced positive results
AI Summary
AstraZeneca and Amgen have announced positive Phase III WAYPOINT trial results for TEZSPIRE® (tezepelumab-ekko) in patients with chronic rhinosinusitis with nasal polyps. The trial showed that TEZSPIRE significantly reduced nasal polyp size, eased nasal congestion, and lessened the need for surgery compared to placebo. Improvements were observed as early as week two and maintained through week 52, with dramatic decreases in systemic corticosteroid use.
Notably, TEZSPIRE nearly eliminated the need for subsequent nasal polyp surgery, reducing surgery rates by 98%, while corticosteroid use dropped by 88%. This partnership highlights TEZSPIRE’s promise as a less invasive treatment that can improve the quality of life for patients with CRSwNP by reducing chronic symptoms and surgical intervention needs.
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AIRSUPRA FDA Regulatory Timeline and Events
AIRSUPRA is a drug developed by Astrazeneca for the following indication: For asthma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AIRSUPRA
- Announced Date:
- September 18, 2025
- Indication:
- For asthma
Announcement
Astrazeneca announced that The BATURA Phase IIIb trial, which evaluated severe exacerbation risk reduction, examined the efficacy of as-needed AIRSUPRA compared to as-needed albuterol,2 the most commonly used rescue medication for asthma in the US. The BATURA trial demonstrated treatment with AIRSUPRA significantly reduced the risk of a severe exacerbation by 46% (hazard ratio [HR] 0.54; 95% confidence interval [CI]: 0.40, 0.72; p<0.001) when compared with albuterol in adult patients with mild asthma.2
AI Summary
AstraZeneca’s Phase IIIb BATURA trial compared as-needed AIRSUPRA with as-needed albuterol in adults with mild asthma. The US-based, randomized, double-blind, event-driven study enrolled over 2,400 participants and met its primary goal of delaying the first severe asthma attack. AIRSUPRA reduced the risk of a severe exacerbation by 46% (hazard ratio 0.54; 95% CI 0.40–0.72; p<0.001) versus albuterol, and also lowered annual rates of attacks and steroid use. The treatment was well tolerated, with a safety profile matching previous studies.
These BATURA results will be added to AIRSUPRA’s US prescribing information to support an anti-inflammatory rescue strategy. As a fixed-dose inhaler combining albuterol and budesonide, AIRSUPRA delivers both fast relief and inflammation control. The trial’s findings build on earlier positive studies and align with guidelines that favor anti-inflammatory rescue therapy over using a short-acting beta agonist alone.
Read Announcement- Drug:
- AIRSUPRA
- Announced Date:
- May 19, 2025
- Indication:
- For asthma
Announcement
AstraZeneca announced that Positive full results from the BATURA Phase IIIb trial showed anti-inflammatory reliever rescue therapy, Airsupra (albuterol/budesonide), demonstrated statistically significant and clinically meaningful improvements in all primary and secondary endpoints compared to albuterol in patients with mild asthma.1,2
Read Announcement- Drug:
- AIRSUPRA
- Announced Date:
- October 7, 2024
- Indication:
- For asthma
Announcement
AstraZeneca announced Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca's AIRSUPRA ® (albuterol/budesonide) met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms compared to as-needed albuterol.1
AI Summary
AstraZeneca reported positive high-level results from the BATURA Phase IIIb trial for its new inhaled medication, AIRSUPRA® (a combination of albuterol and budesonide). The trial showed that when used as an as-needed rescue treatment, AIRSUPRA significantly reduced the risk of a severe asthma exacerbation compared to standard as-needed albuterol. The study, which involved patients with intermittent or mild persistent asthma, met its primary endpoint with statistically significant and clinically meaningful results. Due to the overwhelming efficacy observed, the trial was stopped early by the Independent Data Monitoring Committee. These findings support the use of AIRSUPRA as a first-in-class rescue treatment that not only treats symptoms but also addresses inflammation, potentially helping many patients better manage their asthma and reduce the occurrence of severe breathing difficulties.
Read Announcement
TULIP-SC FDA Regulatory Events
TULIP-SC is a drug developed by Astrazeneca for the following indication: in patients with systemic lupus erythematosus based on an interim analysis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TULIP-SC
- Announced Date:
- September 17, 2025
- Indication:
- in patients with systemic lupus erythematosus based on an interim analysis
Announcement
Astrazenca announced Positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with systemic lupus erythematosus (SLE) showed that the subcutaneous (SC) administration of AstraZeneca's SAPHNELO® (anifrolumab) demonstrated a statistically significant and clinically meaningful reduction in disease activity compared to placebo.1
AI Summary
AstraZeneca reported positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with moderate to severe systemic lupus erythematosus (SLE). The study compared subcutaneous (SC) injections of SAPHNELO® (anifrolumab) against placebo, with all participants also receiving standard therapy (oral corticosteroids, antimalarials and/or immunosuppressants). SC SAPHNELO led to a statistically significant and clinically meaningful reduction in disease activity versus placebo, measured by the British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA) at week 52.
The safety profile of the SC formulation matched that seen with intravenous dosing. These interim findings are now under regulatory review and will be presented at the American College of Rheumatology Convergence 2025. If approved, SC SAPHNELO could offer patients a more flexible and convenient treatment option, helping more people achieve low disease activity or remission in SLE.
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TAGRISSO® (osimertinib) FDA Regulatory Timeline and Events
TAGRISSO® (osimertinib) is a drug developed by Astrazeneca for the following indication: Third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TAGRISSO® (osimertinib)
- Announced Date:
- September 7, 2025
- Indication:
- Third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.
Announcement
AstraZeneca announced Positive results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed AstraZeneca's TAGRISSO® (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS compared to TAGRISSO monotherapy in the 1st-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
AI Summary
AstraZeneca reported that the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed TAGRISSO® (osimertinib) plus pemetrexed and platinum-based chemotherapy significantly improved OS versus TAGRISSO monotherapy in first-line treatment of EGFR-mutated non-small cell lung cancer. The combination cut the risk of death by 23% (hazard ratio 0.77; p=0.0202).
Median OS reached 47.5 months with the combination versus 37.6 months with monotherapy. At three years, 63.1% of patients on the combination were alive compared to 50.9% on osimertinib alone; at four years, survival was 49.1% versus 40.8%. Benefits were consistent across all subgroups.
With a manageable safety profile, these results reinforce TAGRISSO plus chemotherapy as a new first-line standard of care and uphold TAGRISSO’s role as the backbone therapy in EGFR-mutated lung cancer.
Read Announcement- Drug:
- TAGRISSO® (osimertinib)
- Announced Date:
- July 21, 2025
- Indication:
- Third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.
Announcement
AstraZeneca announced Positive high-level results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed AstraZeneca's TAGRISSO® (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS compared to TAGRISSO monotherapy for patients with 1st-line locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
Read Announcement- Drug:
- TAGRISSO® (osimertinib)
- Announced Date:
- June 30, 2025
- Indication:
- Third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.
Announcement
HUTCHMED (China) Limited announces that the New Drug Application ("NDA") for the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) has been granted approval by the China National Medical Products Administration ("NMPA") for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor ("EGFR") mutation-positive non-squamous non-small cell lung cancer ("NSCLC") with MET amplification after disease progression on EGFR tyrosine kinase inhibitor ("TKI") therapy.
AI Summary
HUTCHMED (China) Limited announced that the China National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for a new combination treatment using ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib). This therapy is designed for patients with locally advanced or metastatic, EGFR mutation‐positive non‐squamous non‐small cell lung cancer (NSCLC) who have developed MET amplification after disease progression on EGFR tyrosine kinase inhibitor (TKI) therapy.
The approval is based on the Phase III SACHI trial results, which showed a significant improvement in progression-free survival compared to platinum-based chemotherapy. Notably, this is the only all-oral, chemotherapy-free treatment option available for these patients, addressing a critical resistance mechanism in lung cancer therapy. In addition, the approval triggers an US$11 million milestone payment from AstraZeneca, marking a key advancement in combating lung cancer with targeted therapies in China.
Read Announcement- Drug:
- TAGRISSO® (osimertinib)
- Announced Date:
- March 25, 2025
- Indication:
- Third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.
Announcement
AstraZeneca announces New study results presented at the European Lung Cancer Congress (ELCC) 2025, March 26 to 29, demonstrate the role of AstraZeneca's TAGRISSO® (osimertinib), as monotherapy and as the backbone for novel combinations, across stages and settings of epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
AI Summary
New study results presented at the European Lung Cancer Congress (ELCC) 2025 highlight TAGRISSO® (osimertinib) as both an effective standalone treatment and a foundation for novel treatment combinations in EGFR mutation‐positive non-small cell lung cancer (NSCLC). In the LAURA Phase III trial, TAGRISSO showed a promising overall survival trend in patients with unresectable, Stage III NSCLC after chemoradiotherapy.
Additionally, data from the SAVANNAH and ORCHARD Phase II trials demonstrated that adding savolitinib or datopotamab deruxtecan-dlnk to TAGRISSO upon disease progression resulted in strong clinical activity in advanced NSCLC. These findings reinforce TAGRISSO’s role across various stages of EGFRm NSCLC and support its value in maintaining patient quality of life while extending survival.
Read Announcement- Drug:
- TAGRISSO® (osimertinib)
- Announced Date:
- September 26, 2024
- Indication:
- Third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.
Announcement
AstraZeneca Plc announced that the FDA approved Tagrisso (osimertinib) for adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT).
AI Summary
AstraZeneca announced that the FDA has approved TAGRISSO (osimertinib) for adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) that has an epidermal growth factor receptor mutation. This approval is for patients whose cancer has not grown after concurrent or sequential platinum-based chemoradiation therapy. Specifically, TAGRISSO is available for those with exon 19 deletions or exon 21 (L858R) mutations detected with an FDA-approved test. The decision was based on strong data from the LAURA Phase III trial, which showed that the drug extended median progression-free survival by more than three years. This means patients treated with TAGRISSO experienced a significantly longer period without their disease worsening compared to those who received a placebo, marking an important step forward in treating this subset of lung cancer patients.
Read Announcement- Drug:
- TAGRISSO® (osimertinib)
- Announced Date:
- July 5, 2024
- Indication:
- Third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.
Announcement
AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in the European Union (EU) for the 1st-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
Read Announcement- Drug:
- TAGRISSO® (osimertinib)
- Announced Date:
- June 26, 2024
- Indication:
- Third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.
Announcement
AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in China for the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
Read Announcement- Drug:
- TAGRISSO® (osimertinib)
- Announced Date:
- June 10, 2024
- Target Action Date:
- Q4 2024
- Estimated Target Date Range:
- October 1, 2024 - December 31, 2024
- Indication:
- Third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.
Announcement
AstraZeneca’ announced that The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2024.
AI Summary
AstraZeneca recently submitted a Supplemental New Drug Application (sNDA) for TAGRISSO® (osimertinib) under Priority Review in the United States. The application targets adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) that have specific EGFR mutations. The announcement comes after the encouraging LAURA Phase III trial results, which demonstrated an improvement in median progression-free survival by more than three years compared to placebo.
The company noted that the FDA’s Prescription Drug User Fee Act action date, marking the regulatory decision timeline, is anticipated during the fourth quarter of 2024. This scheduled date represents an important milestone for advancing TAGRISSO as a potential targeted treatment option for patients with this advanced form of lung cancer.
Read Announcement- Drug:
- TAGRISSO® (osimertinib)
- Announced Date:
- June 10, 2024
- Indication:
- Third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.
Announcement
AstraZeneca's supplemental New Drug Application (sNDA) forTAGRISSO®(osimertinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT).
AI Summary
AstraZeneca’s supplemental New Drug Application (sNDA) for TAGRISSO® (osimertinib) has been accepted by the FDA and given Priority Review for treating adult patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) after chemoradiotherapy. This decision is based on the encouraging results of the Phase III LAURA trial, which showed that TAGRISSO extended median progression-free survival by more than three years compared to placebo. The trial data highlighted a significant 84% reduction in the risk of disease progression or death. In addition to Priority Review, TAGRISSO received Breakthrough Therapy Designation, a status that speeds up the review process for promising treatments aimed at addressing serious medical needs. The FDA is anticipated to make a decision in the fourth quarter of 2024, potentially making TAGRISSO a new standard of care for these patients.
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BaxHTN FDA Regulatory Events
BaxHTN is a drug developed by Astrazeneca for the following indication: In patients with uncontrolled or treatment resistant hypertension.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BaxHTN
- Announced Date:
- August 30, 2025
- Indication:
- In patients with uncontrolled or treatment resistant hypertension
Announcement
AstraZeneca's Baxdrostat Met Primary, All Secondary Endpoints In BaxHTN Phase III Trial In Patients With Hard-to-control Hypertension
Read Announcement- Drug:
- BaxHTN
- Announced Date:
- July 14, 2025
- Indication:
- In patients with uncontrolled or treatment resistant hypertension
Announcement
AstraZeneca announced Positive high-level results from the BaxHTN Phase III trial showed baxdrostat at two doses (2mg and 1mg) demonstrated a statistically significant and clinically meaningful reduction in mean seated systolic blood pressure (SBP) compared with placebo at 12 weeks.
AI Summary
AstraZeneca announced positive high-level results from the BaxHTN Phase III trial, showing that baxdrostat significantly reduced mean seated systolic blood pressure (SBP) compared with a placebo. In the study, patients with uncontrolled or treatment-resistant hypertension received baxdrostat at doses of 2mg or 1mg in addition to their standard care. At 12 weeks, both doses demonstrated statistically significant and clinically meaningful reductions in SBP, meeting the trial's primary endpoint. The trial also successfully met all secondary endpoints, further supporting baxdrostat’s potential as a new treatment option for difficult-to-control hypertension. Additionally, the drug was generally well tolerated by participants and had a favorable safety profile. These findings highlight baxdrostat’s promise in targeting aldosterone dysregulation as a novel approach to lower blood pressure and reduce cardiovascular risk.Read Announcement
Gefurulimab FDA Regulatory Events
Gefurulimab is a drug developed by Astrazeneca for the following indication: in adults with generalised myasthenia gravis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- gefurulimab
- Announced Date:
- July 24, 2025
- Indication:
- in adults with generalised myasthenia gravis
Announcement
AstraZeneca announced Positive high-level results from a global, randomised, double-blind, placebo-controlled Phase III trial in adults with anti-acetylcholine receptor (AChR) antibody-positive (Ab+) generalised myasthenia gravis (gMG) showed that gefurulimab met its primary and all secondary endpoints.
AI Summary
AstraZeneca announced positive results from a global Phase III trial of gefurulimab. The trial was randomized, double-blind, and placebo-controlled. It enrolled adults with generalised myasthenia gravis who tested positive for anti-acetylcholine receptor antibodies (AChR Ab+).
Gefurulimab met its primary endpoint, showing an improvement in daily living activities compared to placebo. All secondary endpoints were also achieved, including gains in muscle strength and quality of life scores. These results underline the drug’s benefit.
The safety profile of gefurulimab was favourable, with most side effects being mild or moderate and similar to placebo. No new safety concerns were identified. This data builds confidence in the treatment’s risk and benefit profile.
AstraZeneca plans to present the trial data at conferences and will discuss the next steps with regulators. If approved, gefurulimab could offer a new option for people living with AChR Ab+ generalised myasthenia gravis.
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SERENA-6 FDA Regulatory Timeline and Events
SERENA-6 is a drug developed by Astrazeneca for the following indication: For HR-Positive Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SERENA-6
- Announced Date:
- June 1, 2025
- Indication:
- For HR-Positive Breast Cancer
Announcement
AstraZeneca announced Positive results from the SERENA-6 Phase III trial showed that camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS). T
AI Summary
AstraZeneca announced positive results from its SERENA-6 Phase III trial, showing that camizestrant, when combined with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib), significantly improved progression-free survival (PFS) in patients with HR-positive, HER2-negative advanced breast cancer with an emergent ESR1 mutation.
The trial demonstrated a highly statistically significant 56% reduction in the risk of disease progression or death. Patients who switched to the camizestrant combination had a median PFS of 16 months compared to 9.2 months for those on standard aromatase inhibitor treatment. This improvement was consistent across all types of CDK4/6 inhibitors and various patient groups.
These findings highlight the potential for early treatment changes based on circulating tumor DNA monitoring to delay resistance, offering a promising new approach to extend the benefits of first-line therapy in advanced breast cancer.
Read Announcement- Drug:
- SERENA-6
- Announced Date:
- May 22, 2025
- Indication:
- For HR-Positive Breast Cancer
Announcement
Guardant Health, Inc announced the company and its research collaborators will present data from more than 19 studies, including a landmark plenary session on the Phase 3 SERENA-6 trial, demonstrating the critical role of Guardant liquid biopsy tests in cancer screening, therapy selection and recurrence monitoring at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago.
AI Summary
Guardant Health, Inc. announced that it will present data from over 19 studies at the 2025 ASCO Annual Meeting in Chicago. A highlight is a landmark plenary session on the Phase 3 SERENA-6 trial, which demonstrates the critical role of its Guardant360 CDx liquid biopsy test. This study shows how the test can detect emerging ESR1 mutations in HR+/HER2– advanced breast cancer patients during first-line endocrine therapy, potentially identifying changes in the disease before progression occurs. The findings underscore the expanding use of liquid biopsies in cancer screening, accurate therapy selection, and recurrence monitoring, providing valuable insights for clinicians. Guardant’s presentations also explore the broader applications of its blood tests and advanced profiling technologies, which aim to improve cancer treatment by identifying genomic and epigenomic biomarkers across various solid tumor types.
Read Announcement- Drug:
- SERENA-6
- Announced Date:
- February 26, 2025
- Indication:
- For HR-Positive Breast Cancer
Announcement
AstraZeneca announced Positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial showed that AstraZeneca's camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS).
AI Summary
AstraZeneca’s SERENA-6 Phase III trial met its primary endpoint, showing that camizestrant combined with any of the three approved CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) produced a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS). This planned interim analysis evaluated patients with HR-positive, HER2-negative advanced breast cancer whose tumors had developed an ESR1 mutation while on standard aromatase inhibitor treatment. By using a circulating tumor DNA (ctDNA)-guided approach, the trial switched patients to the camizestrant combination, allowing for early intervention upon signs of endocrine resistance. Though key secondary endpoints such as time to second disease progression (PFS2) and overall survival (OS) are still maturing, early trends indicate further benefit. The favorable safety profile and low discontinuation rates underline the potential of camizestrant as a new, valuable treatment option.
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POTOMAC FDA Regulatory Events
POTOMAC is a drug developed by Astrazeneca for the following indication: for high-risk non-muscle-invasive bladder cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- POTOMAC
- Announced Date:
- May 9, 2025
- Indication:
- for high-risk non-muscle-invasive bladder cancer
Announcement
AstraZeneca announced that PUBLISHED 9 May 2025 Patients lived significantly longer without high-risk disease recurrence or progression after one year of Imfinzi treatment plus Bacillus Calmette-Guérin (BCG) induction and maintenance therapy vs. BCG alone Positive high-level results from the POTOMAC Phase III trial showed one year of treatment with Imfinzi (durvalumab) plus standard-of-care BCG induction and maintenance therapy demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) compared to BCG induction and maintenance therapy alone.
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BREZTRI AEROSPHERE FDA Regulatory Events
BREZTRI AEROSPHERE is a drug developed by Astrazeneca for the following indication: To improve cardiopulmonary outcomes in people with COPD.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BREZTRI AEROSPHERE
- Announced Date:
- May 2, 2025
- Indication:
- To improve cardiopulmonary outcomes in people with COPD
Announcement
AstraZeneca announce Positive high-level results from the Phase III KALOS and LOGOS trials in patients with uncontrolled asthma showed that AstraZeneca's fixed-dose triple-combination therapy BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) met all primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines.
AI Summary
AstraZeneca announced positive high-level results from the Phase III KALOS and LOGOS trials for BREZTRI AEROSPHERE, a fixed-dose triple-combination therapy (budesonide/glycopyrronium/formoterol fumarate, or BGF at 320/28.8/9.6μg) in patients with uncontrolled asthma. The trials showed that BREZTRI met all primary endpoints, offering statistically significant and clinically meaningful improvements in lung function compared to standard dual-combination ICS/LABA treatments. These improvements are particularly important for patients who continue to experience symptoms such as breathlessness, coughing, and wheezing despite current therapies. The robust data suggest that BREZTRI could set a new standard of care in managing uncontrolled asthma, potentially enhancing the quality of life for millions of patients worldwide. AstraZeneca plans to present the full results to regulatory authorities and share more details at an upcoming medical meeting.
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AZP-3601 FDA Regulatory Events
AZP-3601 is a drug developed by Astrazeneca for the following indication: For the treatment of chronic hypoparathyroidism (HypoPT).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AZP-3601
- Announced Date:
- March 17, 2025
- Indication:
- For the treatment of chronic hypoparathyroidism (HypoPT)
Announcement
AstraZeneca announced High-level results from the CALYPSO Phase III trial showed that eneboparatide (AZP-3601), an investigational parathyroid hormone (PTH) receptor 1 agonist, met its primary endpoint with statistical significance in adults with chronic hypoparathyroidism (HypoPT) at 24 weeks, compared to placebo.
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Casdatifan FDA Regulatory Timeline and Events
Casdatifan is a drug developed by Astrazeneca for the following indication: In patients with ccRCC.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- casdatifan
- Announced Date:
- February 15, 2025
- Indication:
- In patients with ccRCC
Announcement
Arcus Biosciences, Inc today presented new data for casdatifan, a HIF-2a inhibitor with best-in-class potential, in an oral plenary session by Dr. Toni K. Choueiri, Dana-Farber Cancer Institute, at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium.
AI Summary
At the 2025 ASCO Genitourinary Cancers Symposium, Arcus Biosciences presented promising new data for casdatifan, a HIF-2a inhibitor with best-in-class potential. During an oral plenary session led by Dr. Toni K. Choueiri from Dana-Farber Cancer Institute, the company shared results from the Phase 1/1b ARC-20 study. The study focused on patients with metastatic clear cell renal cell carcinoma who had previously received multiple lines of therapy. Notably, the 50mg twice-daily casdatifan cohort achieved a 9.7‐month median progression-free survival with improved overall response rates and disease control compared to earlier HIF-2a studies. The favorable outcomes and manageable safety profile of casdatifan support its potential use as a standalone treatment and in combination therapy, laying the groundwork for future pivotal clinical trials.
Read Announcement- Drug:
- casdatifan
- Announced Date:
- October 9, 2024
- Indication:
- In patients with ccRCC
Announcement
Arcus Biosciences, Inc announced four accepted abstracts at the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics being held October 23-25, 2024, in Barcelona, Spain.
AI Summary
Arcus Biosciences, Inc. announced that four abstracts have been accepted for presentation at the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain, from October 23-25. These abstracts highlight key research on their investigational molecules, including casdatifan and AB801. One of the abstracts will be presented in an oral plenary session, showcasing clinical efficacy and safety data from the 100mg daily monotherapy expansion cohort of ARC-20, a Phase 1/1b study evaluating casdatifan in clear cell renal cell carcinoma (ccRCC). Additional posters will detail preclinical evaluations, pharmacokinetics/pharmacodynamics, and the potential of the AXL inhibitor AB801 in sensitizing tumors to standard treatments. Arcus will also host a conference call on October 24 to discuss the ARC-20 results, reinforcing their commitment to advancing innovative cancer therapies with a potential best-in-class profile.
Read Announcement- Drug:
- casdatifan
- Announced Date:
- October 2, 2024
- Indication:
- In patients with ccRCC
Announcement
Arcus Biosciences announced a clinical trial collaboration agreement with AstraZeneca (to evaluate casdatifan (AB521), Arcus's investigational HIF-2a inhibitor, in combination with volrustomig, AstraZeneca's investigational PD-1/CTLA-4 bispecific antibody, in patients with ccRCC.
AI Summary
Arcus Biosciences has announced a new clinical trial collaboration with AstraZeneca to test a promising combination treatment for clear cell renal cell carcinoma (ccRCC), a common type of kidney cancer. The study will evaluate Arcus’s casdatifan (AB521), an investigational HIF-2α inhibitor, together with AstraZeneca’s volrustomig, an experimental PD-1/CTLA-4 bispecific antibody. AstraZeneca will sponsor the trial, which aims to assess the safety and early effectiveness of this combination in patients with advanced ccRCC. Both companies hope that combining these two agents may lead to deeper and longer-lasting responses in patients. The novel approach builds on early encouraging data from previous studies, offering a potential new treatment option for those battling this aggressive cancer. Neither drug has been approved yet, but this collaboration represents a significant step forward in the search for improved therapies for ccRCC.
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Capivasertib FDA Regulatory Events
Capivasertib is a drug developed by Astrazeneca for the following indication: In patients with locally advanced (inoperable) or metastatic triple-negative breast cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- capivasertib
- Announced Date:
- November 25, 2024
- Indication:
- In patients with locally advanced (inoperable) or metastatic triple-negative breast cancer
Announcement
AstraZeneca announced that Positive high-level results from the CAPItello-281 Phase III trial showed that AstraZeneca's Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC).
AI Summary
AstraZeneca announced positive high-level results from the CAPItello-281 Phase III trial. The study found that TRUQAP (capivasertib), when combined with abiraterone and androgen deprivation therapy (ADT), significantly improved radiographic progression-free survival (rPFS) compared to abiraterone and ADT with a placebo. This trial specifically focused on patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer, an aggressive form with poor outcomes.
Although overall survival data remains immature, early trends suggest a potential benefit. This marks the first time an AKT inhibitor has shown benefit in this specific prostate cancer subtype, offering a promising new treatment option for a patient population with limited alternatives.
Read Announcement - Drug:
- capivasertib
- Announced Date:
- June 18, 2024
- Indication:
- In patients with locally advanced (inoperable) or metastatic triple-negative breast cancer
Announcement
AstraZeneca announced that The CAPItello-290 Phase III trial for Truqap (capivasertib) in combination with paclitaxel in patients with locally advanced (inoperable) or metastatic triple-negative breast cancer (TNBC) did not meet the dual primary endpoints of improvement in overall survival (OS) versus paclitaxel in combination with placebo in either the overall trial population or in a subgroup of patients with tumours harbouring specific biomarker alterations (PIK3CA, AKT1 or PTEN).
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SAPHNELO (anifrolumab) FDA Regulatory Events
SAPHNELO (anifrolumab) is a drug developed by Astrazeneca for the following indication: Moderate to Severe Systemic Lupus Erythematosus BW.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SAPHNELO (anifrolumab)
- Announced Date:
- September 19, 2024
- Indication:
- Moderate to Severe Systemic Lupus Erythematosus BW
Announcement
AstraZeneca announced the initiation of two Phase III trials, LAVENDER and JASMINE, investigating SAPHNELO® (anifrolumab) in two autoimmune diseases.
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Imfinzi + tremelimumab (HIMALAYA) FDA Regulatory Events
Imfinzi + tremelimumab (HIMALAYA) is a drug developed by Astrazeneca for the following indication: First line Hepatocellular carcinoma (HCC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Imfinzi + tremelimumab (HIMALAYA)
- Announced Date:
- September 16, 2024
- Indication:
- First line Hepatocellular carcinoma (HCC)
Announcement
AstraZeneca Updated results from the HIMALAYA Phase III trial showed AstraZeneca's IMFINZI® (durvalumab) plus IMJUDO®(tremelimumab-actl) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localized treatment
AI Summary
Updated results from the HIMALAYA Phase III trial indicate that AstraZeneca’s dual immunotherapy treatment—IMFINZI® (durvalumab) plus IMJUDO® (tremelimumab-actl)—provides a lasting overall survival benefit for patients with unresectable hepatocellular carcinoma. These patients had not received prior systemic therapy and were not candidates for localized treatment. In the trial’s five‐year follow-up, the STRIDE regimen—a single priming dose of IMJUDO added to continued IMFINZI—reduced the risk of death by 24% compared to sorafenib. Approximately 19.6% of patients treated with the STRIDE regimen were alive at five years, compared with 9.4% of those on sorafenib. This sustained benefit highlights the potential of combining these immunotherapies to significantly improve long-term outcomes in advanced liver cancer treatment.
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LYNPARZA (Olaparib) FDA Regulatory Events
LYNPARZA (Olaparib) is a drug developed by Astrazeneca for the following indication: BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYNPARZA (Olaparib)
- Announced Date:
- August 14, 2024
- Indication:
- BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
Announcement
AstraZeneca announced that Lynparza (olaparib) have been approved in the European Union (EU) as treatment for certain patients with primary advanced or recurrent endometrial cancer.
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VOYDEYA FDA Regulatory Events
VOYDEYA is a drug developed by Astrazeneca for the following indication: For treatment of extravascular hemolysis in adults with the rare disease PNH.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VOYDEYA
- Announced Date:
- July 23, 2024
- Indication:
- For treatment of extravascular hemolysis in adults with the rare disease PNH
Announcement
AstraZeneca announced that Voydeya (danicopan tablets) has been approved in Canada as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have residual hemolytic anemia due to extravascular hemolysis (EVH).1
AI Summary
AstraZeneca announced that Voydeya (danicopan tablets) has been approved in Canada as an add-on treatment for adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who continue to experience residual hemolytic anemia due to extravascular hemolysis (EVH). This approval allows Voydeya to be used alongside ravulizumab or eculizumab, offering a new option for the 10-20% of PNH patients who do not fully respond to standard C5 inhibitors. The decision was supported by the results of the ALPHA Phase III trial, which showed that adding Voydeya improved hemoglobin levels, reduced anemia, and alleviated fatigue.
This new oral Factor D inhibitor provides hope for patients by enhancing disease control and quality of life, especially for those still facing the challenges of significant EVH despite ongoing treatment with ravulizumab or eculizumab.
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Sipavibart FDA Regulatory Events
Sipavibart is a drug developed by Astrazeneca for the following indication: for COVID-19 prevention.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- sipavibart
- Announced Date:
- July 1, 2024
- Indication:
- for COVID-19 prevention
Announcement
AstraZeneca’s Marketing Authorisation Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients.
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FARXIGA (dapagliflozin) FDA Regulatory Events
FARXIGA (dapagliflozin) is a drug developed by Astrazeneca for the following indication: chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D).
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FARXIGA (dapagliflozin)
- Announced Date:
- June 12, 2024
- Indication:
- chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D)
Announcement
AstraZeneca's FARXIGA® (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older.1
AI Summary
The US Food and Drug Administration (FDA) has approved AstraZeneca’s FARXIGA® (dapagliflozin) to help improve glycemic control in pediatric patients with type-2 diabetes who are 10 years and older. This decision follows positive results from the T2NOW Phase III trial, one of the largest studies to evaluate treatment options for young patients with T2D. The trial demonstrated significant reductions in A1C levels among children and adolescents, providing strong evidence of FARXIGA’s benefits in managing blood sugar levels. This approval marks an important step forward in addressing the growing challenge of type-2 diabetes in younger populations, who often face earlier onset of complications. With this new treatment option available, healthcare providers now have an additional tool to help improve the quality of life for pediatric patients dealing with this chronic condition.
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