This section highlights FDA-related milestones and regulatory updates for drugs developed by BeiGene (BGNE).
Over the past two years, BeiGene has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BGB-16673, BLINCYTO, BRUKINSA®, Ociperlimab, TEVIMBRA, and Tislelizumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BGB-16673 - FDA Regulatory Timeline and Events
BGB-16673 is a drug developed by BeiGene for the following indication: For adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
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:
- BGB-16673
- Announced Date:
- August 26, 2024
- Indication:
- For adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL)
Announcement
BeiGene, Ltd announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BGB-16673, an orally available investigational Bruton's tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC), for adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have been previously treated with at least two prior lines of therapy, including BTK inhibitor (BTKi) and B-cell lymphoma 2 (BCL2) inhibitor.
AI Summary
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BeiGene’s investigational drug BGB-16673. This orally available BTK-targeting chimeric degradation activation compound (CDAC) is designed for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have already undergone at least two prior treatments, including BTK inhibitors and BCL2 inhibitors.
The Fast Track status is intended to speed up the review process for drugs that treat serious conditions. BGB-16673 has shown promising safety and efficacy in a Phase 1/2 study, suggesting it could fill an important gap in treatment options for patients who have limited choices. This designation highlights the potential of BGB-16673 to address unmet medical needs in CLL/SLL therapy.
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BLINCYTO (Blinatumomab) - FDA Regulatory Timeline and Events
BLINCYTO (Blinatumomab) is a drug developed by BeiGene for the following indication: Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL).
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:
- BLINCYTO (Blinatumomab)
- Announced Date:
- December 7, 2024
- Indication:
- Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)
Announcement
Amgen announced new data demonstrating that adding BLINCYTO® (blinatumomab) to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse.
AI Summary
Amgen recently announced breakthrough Phase 3 study data showing that adding BLINCYTO® (blinatumomab) to chemotherapy improves outcomes in newly diagnosed pediatric patients with National Cancer Institute standard risk B-cell acute lymphoblastic leukemia (B-ALL) who are at average or higher risk of relapse. The study, conducted by the Children’s Oncology Group, found that patients receiving the combination therapy achieved a three-year disease-free survival (DFS) rate of 96%, compared to 87.9% for those treated with chemotherapy alone. This significant improvement represents a 61% reduction in the risk of disease relapse, secondary malignant neoplasms, or remission death. The encouraging results support BLINCYTO® as a critical addition to current treatment strategies, potentially offering similar positive outcomes in standard risk patients as seen in those with more favorable profiles.
Read Announcement- Drug:
- BLINCYTO (Blinatumomab)
- Announced Date:
- June 14, 2024
- Indication:
- Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)
Announcement
Amgen announced the U.S. Food and Drug Administration (FDA) has approved BLINCYTO® (blinatumomab) for the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status.
AI Summary
The U.S. Food and Drug Administration (FDA) has approved BLINCYTO® (blinatumomab) for treating adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) during the consolidation phase of treatment. This approval is significant because it allows the use of BLINCYTO® as part of multiphase consolidation chemotherapy, regardless of whether measurable residual disease (MRD) is detected.
By engaging T cells to target and kill cancer cells, this first-in-class bispecific T-cell engager offers a new treatment option that can potentially improve overall survival rates. The decision follows promising clinical trial results, which demonstrated that adding BLINCYTO® to chemotherapy significantly reduced the risk of death compared to chemotherapy alone. As a result, patients battling B-ALL now have access to a more effective therapy during a critical phase of their treatment journey.
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BRUKINSA® (zanubrutinib) - FDA Regulatory Timeline and Events
BRUKINSA® (zanubrutinib) is a drug developed by BeiGene for the following indication: Inhibitor of Bruton's tyrosine kinase.
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:
- BRUKINSA® (zanubrutinib)
- Announced Date:
- June 11, 2025
- Indication:
- Inhibitor of Bruton's tyrosine kinase
Announcement
BeOne Medicines Ltd announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of BRUKINSA® (zanubrutinib) for all five approved indications.
AI Summary
BeOne Medicines Ltd announced that the FDA approved a new tablet formulation of BRUKINSA® (zanubrutinib) for all five approved indications. The new tablet is designed to simplify treatment by reducing the pill burden, offering patients a more convenient dosing option. Each tablet contains 160 mg, so patients will take two tablets a day instead of four 80 mg capsules, while maintaining the same safety and effectiveness. This change is expected to improve the overall treatment experience for individuals facing B-cell cancers such as chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma. Additionally, BRUKINSA remains unique among BTK inhibitors with its flexible dosing options and recommended use in patients with severe hepatic impairment. The tablet formulation will replace the current capsules starting in October 2025.
Read Announcement- Drug:
- BRUKINSA® (zanubrutinib)
- Announced Date:
- May 31, 2025
- Indication:
- Inhibitor of Bruton's tyrosine kinase
Announcement
BeOne Medicines Ltd. today will present new data from the Arm C and D cohorts of the pivotal, global Phase 3 SEQUOIA trial of BRUKINSA® (zanubrutinib).
AI Summary
BeOne Medicines Ltd. announced that it will present new data from the Arm C and D cohorts of the global Phase 3 SEQUOIA trial at the upcoming ASCO Annual Meeting. The data highlights BRUKINSA® (zanubrutinib)’s strong performance in treating patients with chronic lymphocytic leukemia (CLL), including those with high-risk mutations. In Arm D, the combination of BRUKINSA with venetoclax produced a high 24-month progression-free survival rate of 92% and led to deep, durable responses among treatment-naïve patients, even in those with del(17p) and TP53 mutations. Additionally, some patients reached undetectable minimal residual disease, allowing for treatment discontinuation while maintaining remission. Arm C, which focused on BRUKINSA monotherapy, demonstrated sustained overall and progression-free survival over a 5-year follow-up in difficult-to-treat del(17p) CLL patients, reinforcing the drug’s consistent efficacy across different patient types.
Read Announcement- Drug:
- BRUKINSA® (zanubrutinib)
- Announced Date:
- May 22, 2025
- Indication:
- Inhibitor of Bruton's tyrosine kinase
Announcement
BeiGene, Ltd. announced it will share 23 abstracts featuring new data across its hematology and solid tumor portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, May 30 – June 3, 2025.
AI Summary
BeiGene, Ltd. announced plans to present 23 abstracts at the ASCO Annual Meeting in Chicago, IL, from May 30 to June 3, 2025. These abstracts cover new data from its hematology and solid tumor portfolio. Notably, two abstracts have been selected for rapid oral presentations, highlighting the company’s active role in advancing cancer research. The data include long-term insights into BRUKINSA as a first-line treatment for chronic lymphocytic leukemia and new clinical findings from its emerging breast cancer pipeline. This presentation of diverse research findings reflects BeiGene’s commitment to developing innovative cancer therapies that can improve treatment outcomes and expand patient access worldwide. The company’s participation at ASCO underscores its strategy to address multiple cancer types through robust, data-driven research initiatives.
Read Announcement- Drug:
- BRUKINSA® (zanubrutinib)
- Announced Date:
- May 14, 2025
- Indication:
- Inhibitor of Bruton's tyrosine kinase
Announcement
BeiGene, Ltd. announced it will share data across a range of hematologic malignancies at the European Hematology Association (EHA) Congress in Milan, Italy, June 12–15. BeiGene has 31 abstracts accepted at EHA 2025, with four selected for oral presentations, featuring data from its best-in-class Bruton's tyrosine kinase (BTK) inhibitor BRUKINSA® (zanubrutinib) and its investigational pipeline assets – a next-generation BCL2 inhibitor, sonrotoclax, and BTK protein degrader, BGB-16673.
AI Summary
BeiGene, Ltd. announced it will share significant hematologic malignancy study data at the upcoming European Hematology Association (EHA) Congress in Milan from June 12–15, 2025. The company has secured 31 abstracts for the event, with four designated for oral presentations. These sessions will highlight updated clinical findings on their leading BTK inhibitor, BRUKINSA® (zanubrutinib), alongside key insights into their investigational therapies. Specifically, the congress will feature promising data from their BTK protein degrader, BGB-16673, and the next-generation BCL2 inhibitor, sonrotoclax.
These innovative programs are being explored across various B-cell malignancies, including chronic lymphocytic leukemia, Waldenström’s macroglobulinemia, and mantle cell lymphoma. The data presented at EHA 2025 underscores BeiGene’s commitment to pioneering targeted, next-generation treatments aimed at transforming the standard of care in hematology.
Read Announcement- Drug:
- BRUKINSA® (zanubrutinib)
- Announced Date:
- December 9, 2024
- Indication:
- Inhibitor of Bruton's tyrosine kinase
Announcement
BeiGene, Ltd announced the presentation of new clinical data at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, underscoring its leadership in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) through continued clinical success with BRUKINSA® (zanubrutinib) and promising advancements in its pipeline assets.
AI Summary
BeiGene, Ltd presented new clinical data at the 66th American Society of Hematology Annual Meeting, underscoring its leadership in treating chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The company highlighted continued success with BRUKINSA® (zanubrutinib), noting long-term follow-up from the SEQUOIA study that showed a 71% reduction in the risk of progression or death compared to standard chemotherapy. This robust performance supports BRUKINSA’s role as a best-in-class option in both frontline and relapsed settings.
Additionally, BeiGene shared promising advancements in its pipeline, including encouraging early results from a fixed-duration combination of BRUKINSA with sonrotoclax, a next-generation BCL2 inhibitor, as well as positive data for their BTK degrader, BGB-16673, in treatment-resistant cases. These findings reinforce BeiGene’s commitment to advancing innovative treatment options for CLL/SLL patients worldwide.
Read Announcement- Drug:
- BRUKINSA® (zanubrutinib)
- Announced Date:
- June 14, 2024
- Indication:
- Inhibitor of Bruton's tyrosine kinase
Announcement
BeiGene, Ltd. announced the presentation of new data from the SEQUOIA study of BRUKINSA® (zanubrutinib) today at the European Hematology Association 2024 Hybrid Congress (EHA2024) in Madrid, Spain in an oral session (Abstract S160).
AI Summary
BeiGene, Ltd. announced today at the European Hematology Association 2024 Hybrid Congress in Madrid that new data from the SEQUOIA study for BRUKINSA® (zanubrutinib) will be presented in an oral session (Abstract S160). The study’s Arm D focused on treatment-naïve patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma carrying del(17p) and/or TP53 mutations. Preliminary results from 65 response-evaluable patients showed a 100% overall response rate, with 48% achieving complete response or complete response with incomplete hematopoietic recovery. The combination treatment of BRUKINSA with the BCL2 inhibitor venetoclax demonstrated promising efficacy and tolerability, and the safety profile matched previous studies. These findings offer promising insights into the potential of this combination therapy for high-risk CLL patients, highlighting its role in improving outcomes for a patient group that typically faces a poor prognosis.
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Ociperlimab - FDA Regulatory Timeline and Events
Ociperlimab is a drug developed by BeiGene for the following indication: Locally advanced, unresectable, or 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:
- Ociperlimab
- Announced Date:
- April 3, 2025
- Indication:
- Locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC)
Announcement
BeiGene, Ltd announced the discontinuation of its clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody, as a potential treatment for lung cancer.
AI Summary
BeiGene, Ltd. has announced that it is discontinuing the clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody aimed at treating lung cancer. The decision follows a recommendation by the Independent Data Monitoring Committee to halt the Phase 3 AdvanTIG-302 trial after a planned futility analysis. The analysis indicated that the study was unlikely to meet its primary endpoint of improving overall survival, although no new safety concerns were reported during the trial.
The company stated that by ending the ociperlimab program, it can focus its resources on more promising candidates in its oncology pipeline. BeiGene remains committed to the development of innovative cancer treatments that are affordable and accessible to patients around the world. Future results from the study will be shared later to further scientific understanding of anti-TIGIT activity.
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TEVIMBRA - FDA Regulatory Timeline and Events
TEVIMBRA is a drug developed by BeiGene for the following indication: For the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).
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:
- TEVIMBRA
- Announced Date:
- May 27, 2025
- Indication:
- For the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC)
Announcement
BeiGene, Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA® (tislelizumab), in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC.
AI Summary
BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion on TEVIMBRA® (tislelizumab). This recommendation supports its use in combination with gemcitabine and cisplatin for first-line treatment of adult patients with recurrent, non-operable, or metastatic nasopharyngeal cancer (NPC).
The decision is based on encouraging results from the Phase 3 RATIONALE-309 study. In this trial, treatment with TEVIMBRA plus chemotherapy significantly improved progression-free survival compared to chemotherapy alone. Specifically, the study showed that the median progression-free survival was 9.2 months for the combination arm versus 7.4 months for the placebo group. These findings highlight a robust clinical benefit, suggesting that TEVIMBRA could reduce the risk of disease progression or death for patients who cannot undergo curative surgery or radiotherapy.
Read Announcement- Drug:
- TEVIMBRA
- Announced Date:
- March 4, 2025
- Indication:
- For the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC)
Announcement
BeiGene, Ltd announced the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).
AI Summary
BeiGene, Ltd announced that the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr) for use in combination with platinum-containing chemotherapy. This treatment is now approved as a first-line option for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 at levels of 1% or greater. The decision was based on a global Phase 3 trial, which demonstrated a significant overall survival benefit. In the study, patients with PD-L1 levels of at least 1% had a median overall survival of 16.8 months compared to 9.6 months for those treated with a placebo plus chemotherapy, indicating a 34% reduction in the risk of death. This approval offers new hope for ESCC patients, addressing a critical need for more effective treatment options in this challenging disease area.
Read Announcement- Drug:
- TEVIMBRA
- Announced Date:
- December 27, 2024
- Indication:
- For the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC)
Announcement
BeiGene, Ltd. announced the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1).
AI Summary
BeiGene, Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr) in combination with platinum and fluoropyrimidine-based chemotherapy as a first-line treatment for adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1). This new indication is based on outcomes from the global RATIONALE-305 Phase 3 trial. The study showed that patients receiving TEVIMBRA with chemotherapy experienced a median overall survival of 15.0 months compared to 12.9 months with chemotherapy alone, translating into a 20% reduction in the risk of death. The approval marks a significant advancement in treatment options for patients facing these aggressive cancers, offering a new potential pathway to improve survival and quality of life.Read Announcement
- Drug:
- TEVIMBRA
- Announced Date:
- November 27, 2024
- Indication:
- For the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC)
Announcement
BeiGene, Ltd. announced that the European Commission has approved TEVIMBRA® (tislelizumab) in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
AI Summary
BeiGene, Ltd. announced that the European Commission has approved TEVIMBRA® (tislelizumab) in combination with chemotherapy for first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. This new approval targets adult patients with unresectable, locally advanced, or metastatic cancer whose tumors express PD-L1 with a tumor area positivity score of 5% or higher.
The decision was supported by two positive Phase 3 studies that showed statistically significant overall survival benefits, offering an important new therapeutic option for patients with these aggressive cancers. TEVIMBRA has already been a key part of BeiGene’s solid tumor portfolio, with over 1.3 million patients treated globally, and this approval further expands its use in the European Union.
Read Announcement- Drug:
- TEVIMBRA
- Announced Date:
- September 27, 2024
- Indication:
- For the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC)
Announcement
BeiGene, Ltd announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recognizes the favorable benefit-risk profile of PD-1 inhibitors, including TEVIMBRA® (tislelizumab-jsgr), for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) expressing PD-L1 (>1%) and gastric/gastroesophageal junction (G/GEJ) cancers expressing PD-L1 >1%.
AI Summary
BeiGene announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) recognized the favorable benefit-risk profile of PD-1 inhibitors, including TEVIMBRA® (tislelizumab-jsgr). The committee supported the use of these treatments as a first-line option for patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 above 1%, as well as for gastric/gastroesophageal junction (G/GEJ) cancers with the same PD-L1 expression level.
ODAC members voted to recommend a class-wide PD-L1 expression cut-off of greater than 1% based on safety and efficacy data from Phase 3 studies. This decision helps establish a standard for using PD-1 inhibitors in these patient populations and supports BeiGene’s efforts. The company is currently awaiting further FDA review of its Biologics License Applications (BLAs) for TEVIMBRA in these specific indications.
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Tislelizumab - FDA Regulatory Timeline and Events
Tislelizumab is a drug developed by BeiGene for the following indication: Recurrent or Metastatic Nasopharyngeal 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:
- Tislelizumab
- Announced Date:
- March 31, 2025
- Indication:
- Recurrent or Metastatic Nasopharyngeal Cancer
Announcement
BeiGene, Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA® (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC).
AI Summary
BeiGene, Ltd. received positive news from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The CHMP recommended approval of TEVIMBRA® (tislelizumab) for use in adult patients with extensive-stage small cell lung cancer (ES-SCLC). When used together with etoposide and platinum chemotherapy, TEVIMBRA showed a statistically significant overall survival benefit in the Phase 3 RATIONALE-312 study. In this study, patients receiving the combination treatment had a median overall survival of 15.5 months compared to 13.5 months with chemotherapy and placebo, marking a 25% reduction in the risk of death.
This positive opinion from the CHMP supports TEVIMBRA’s potential as an important first-line treatment option for ES-SCLC, offering hope for improved patient outcomes in a disease with limited treatment choices.
Read Announcement- Drug:
- Tislelizumab
- Announced Date:
- January 7, 2025
- Indication:
- Recurrent or Metastatic Nasopharyngeal Cancer
Announcement
MAIA Biotechnology, Inc announced that it has entered into a clinical supply agreement with global oncology company BeiGene to assess the efficacy of THIO, its small molecule telomere-targeting anticancer agent, in combination with BeiGene's immune checkpoint inhibitor (CPI) tislelizumab in three cancer indications.
AI Summary
MAIA Biotechnology, Inc. announced a clinical supply agreement with global oncology company BeiGene. Under the agreement, MAIA will sponsor Phase 2 pivotal trials to evaluate THIO, a small molecule telomere-targeting anticancer agent, in combination with BeiGene’s immune checkpoint inhibitor (CPI) tislelizumab. The trials will focus on three cancer indications: hepatocellular carcinoma, small cell lung cancer, and colorectal cancer.
This collaboration aims to assess whether the combination can enhance the anti-tumor immune response, potentially turning immunologically inactive “cold” tumors into “hot” ones that are more responsive to treatment. MAIA will fund and lead the clinical studies, while BeiGene provides tislelizumab. The partnership builds on promising preclinical results, offering hope for advanced therapies in deadly cancers.
Read Announcement- Drug:
- Tislelizumab
- Announced Date:
- September 26, 2024
- Indication:
- Recurrent or Metastatic Nasopharyngeal Cancer
Announcement
BeiGene, Ltd. announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recognizes the favorable benefit-risk profile of PD-1 inhibitors, including TEVIMBRA® (tislelizumab-jsgr), for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) expressing PD-L1 (>1%) and gastric/gastroesophageal junction (G/GEJ) cancers expressing PD-L1 >1%.
AI Summary
BeiGene announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has recognized the favorable benefit-risk profile of PD-1 inhibitors, including their drug TEVIMBRA® (tislelizumab-jsgr), for first-line treatment of patients with advanced esophageal squamous cell carcinoma (ESCC) and gastric/gastroesophageal junction (G/GEJ) cancers when PD-L1 is expressed at levels above 1%. This endorsement followed a review of data from major clinical studies, including RATIONALE-305 and RATIONALE-306, which showed significant survival benefits. The committee’s vote established a class-wide PD-L1 expression cut-off to help clinicians decide treatment options for patients with these aggressive cancers. BeiGene is now looking forward to working with the FDA as it reviews the Biologics License Applications (BLAs) for TEVIMBRA in these indications, aiming to offer more effective treatment choices in the U.S.
Read Announcement
