This section highlights FDA-related milestones and regulatory updates for drugs developed by Amgen (AMGN).
Over the past two years, Amgen has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BLINCYTO, IMDELLTRATM, LUMAKRAS®, Otezla, Tarlatamab, tezepelumab-ekko, and TEZSPIRE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BLINCYTO (Blinatumomab) - FDA Regulatory Timeline and Events
BLINCYTO (Blinatumomab) is a drug developed by Amgen 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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IMDELLTRATM - FDA Regulatory Timeline and Events
IMDELLTRATM is a drug developed by Amgen for the following indication: In Small Cell Lung 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:
- IMDELLTRATM
- Announced Date:
- September 9, 2024
- Indication:
- In Small Cell Lung Cancer
Announcement
Amgen announced the presentation of new data showcasing IMDELLTRATM (tarlatamab-dlle), a first-in-class delta-like ligand 3 (DLL3)-targeting Bispecific T-cell Engager (BiTE®) molecule, at the 2024 World Conference on Lung Cancer (WCLC) in San Diego.
AI Summary
At the 2024 World Conference on Lung Cancer in San Diego, Amgen announced new data on its groundbreaking drug IMDELLTRA (tarlatamab-dlle). This first-in-class delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) is designed to harness the body’s immune system to fight small cell lung cancer. The data was showcased during two oral presentations in the “DLL3 Targeting BiTE Therapies in SCLC” session. One presentation detailed results from the global Phase 1b DeLLphi-303 study, which examined IMDELLTRA in combination with a PD-L1 inhibitor as a first-line maintenance therapy for patients with extensive-stage small cell lung cancer. Early findings suggest a manageable safety profile with encouraging disease control. Another presentation highlighted long-term results from a Phase 2 trial in patients previously treated for this aggressive cancer, supporting IMDELLTRA’s potential as a targeted immunotherapy option.
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LUMAKRAS® (SOTORASIB) - FDA Regulatory Timeline and Events
LUMAKRAS® (SOTORASIB) is a drug developed by Amgen for the following indication: For adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC).
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:
- LUMAKRAS® (SOTORASIB)
- Announced Date:
- January 17, 2025
- Indication:
- For adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC)
Announcement
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
AI Summary
Amgen announced that the U.S. FDA has approved LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) for adult patients with KRAS G12C-mutated metastatic colorectal cancer. This approval applies to patients who have already received chemotherapy treatments based on fluoropyrimidine, oxaliplatin, and irinotecan, and whose mutation has been confirmed by an FDA-approved test. The decision comes after promising results from the pivotal Phase 3 CodeBreaK 300 study. This study demonstrated that the combination treatment doubled progression-free survival compared to the standard care. As the first targeted therapy duo specifically addressing KRAS G12C-mutated mCRC in the chemorefractory setting, this new treatment option offers hope for improved management of a challenging and aggressive form of cancer, paving the way for future advancements in precision medicine for colorectal cancer patients.
Read Announcement- Drug:
- LUMAKRAS® (SOTORASIB)
- Announced Date:
- May 28, 2024
- Indication:
- For adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC)
Announcement
Amgen announced the presentation of new data from its broad oncology portfolio at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, taking place from May 31-June 4 in Chicago.
AI Summary
Amgen announced it will present new clinical data from its extensive oncology portfolio at the ASCO 2024 Annual Meeting in Chicago, scheduled from May 31 to June 4. The presentation will feature 17 abstracts from Amgen-sponsored and partner-led studies, highlighting the company’s ongoing commitment to developing impactful treatments for hard-to-treat cancers. Among the data shared, significant focus is given to immunotherapy advances, including results from studies evaluating bispecific T-cell engager therapies such as IMDELLTRA™ (tarlatamab-dlle) in small cell lung cancer. Additionally, Amgen will present data on an innovative combination treatment approach using LUMAKRAS® (sotorasib) with Vectibix® (panitumumab) in patients with KRAS G12C-mutated metastatic colorectal cancer. This work underscores Amgen’s goal to target key molecular drivers of cancer and improve patient outcomes across various tumor types.
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Otezla (Apremilast) - FDA Regulatory Timeline and Events
Otezla (Apremilast) is a drug developed by Amgen for the following indication: Mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy.
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:
- Otezla (Apremilast)
- Announced Date:
- August 20, 2024
- Indication:
- Mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy
Announcement
Amgen announced Otezla® (apremilast) is now available in the U.S. for pediatric use.
AI Summary
Amgen announced that Otezla® (apremilast) is now available in the U.S. for pediatric patients. The FDA approved its use for children and adolescents aged 6 to 17 who weigh at least 20 kg (44 lb) and have moderate to severe plaque psoriasis. This approval marks the first time an oral treatment option is available for this young patient group, providing an alternative to the current injection or infusion therapies.
The decision was supported by a robust Phase 3 study where patients met key endpoints showing clear or nearly clear skin by week 16 of treatment. The new oral option offers hope for children suffering from uncomfortable, visible symptoms such as itchy and dry lesions. The approval gives caregivers and patients a simpler treatment method while aiming to improve quality of life through effective disease management.
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Tarlatamab - FDA Regulatory Timeline and Events
Tarlatamab is a drug developed by Amgen for the following indication: Small cell lung cancer (SCLC).
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:
- Tarlatamab
- Announced Date:
- May 16, 2024
- Indication:
- Small cell lung cancer (SCLC)
Announcement
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved IMDELLTRA™ (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy
AI Summary
Amgen announced that the FDA has approved the new treatment IMDELLTRA™ (tarlatamab-dlle) for adult patients with extensive-stage small cell lung cancer (ES-SCLC) who experience disease progression after platinum-based chemotherapy. This approval marks a significant advancement in the treatment of ES-SCLC, a form of lung cancer that is often difficult to manage after initial treatments fail. The FDA’s decision followed a careful review of clinical data that showed the potential benefits of the drug, giving hope to patients with advanced disease who have limited options. With IMDELLTRA, doctors now have another tool in their arsenal to address this aggressive cancer. The new treatment is expected to offer improved outcomes and an alternative for patients whose cancer has continued to progress despite standard chemotherapy protocols.
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tezepelumab-ekko - FDA Regulatory Timeline and Events
tezepelumab-ekko is a drug developed by Amgen 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:
- 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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TEZSPIRE - FDA Regulatory Timeline and Events
TEZSPIRE is a drug developed by Amgen for the following indication: in chronic obstructive pulmonary disease.
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:
- TEZSPIRE
- Announced Date:
- May 19, 2024
- Indication:
- in chronic obstructive pulmonary disease
Announcement
Amgen Inc and AstraZeneca Plc announced the results of the Phase 2a COURSE trial of Tezspire (tezepelumab-ekko) for severe chronic obstructive pulmonary disease (COPD) with a broad range of baseline blood eosinophil counts (BEC) irrespective of emphysema,
AI Summary
Amgen Inc. and AstraZeneca Plc announced positive findings from the Phase 2a COURSE trial for Tezspire (tezepelumab-ekko) in patients with moderate to very severe COPD. The trial included patients with a broad range of blood eosinophil counts, regardless of emphysema status. Overall, treatment with Tezspire led to a 17% reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo, although this result was not statistically significant.
Notably, in patients with baseline eosinophil counts of ≥150 cells/µL, there was a 37% reduction in COPD flare-ups, while those with counts ≥300 cells/µL experienced a 46% decrease. These results suggest that Tezspire has a beneficial impact across a wide range of COPD patients and support plans for further evaluation in a Phase 3 clinical program.
Read Announcement- Drug:
- TEZSPIRE
- Announced Date:
- May 19, 2024
- Indication:
- in chronic obstructive pulmonary disease
Announcement
Amgen announced the results of the Phase 2a COURSE trial evaluating Tezspire® (tezepelumab-ekko) in people with moderate to very severe chronic obstructive pulmonary disease (COPD) with a broad range of baseline blood eosinophil counts (BEC) irrespective of emphysema, chronic bronchitis or smoking status.
AI Summary
Amgen recently announced results from the Phase 2a COURSE trial, which evaluated Tezspire® (tezepelumab-ekko) in patients with moderate to very severe COPD. The study included participants with a wide range of blood eosinophil counts, regardless of whether they had emphysema, chronic bronchitis, or a history of smoking. Overall, there was a 17% numerical reduction in the rate of moderate or severe COPD exacerbations compared to placebo after 52 weeks, although this result was not statistically significant. However, for patients with baseline blood eosinophil counts of 150 cells/µL or higher, Tezspire showed a 37% reduction in exacerbations, and even a 46% reduction was seen in those with counts of 300 cells/µL or higher. These findings support further evaluation, and Amgen is planning a Phase 3 program to confirm Tezspire’s potential benefits for COPD patients.
Read Announcement- Drug:
- TEZSPIRE
- Announced Date:
- April 16, 2024
- Indication:
- in chronic obstructive pulmonary disease
Announcement
Amgen provided an update regarding the results of the Phase 2a COURSE trial for TEZSPIRE® (tezepelumab-ekko) in chronic obstructive pulmonary disease (COPD), which were accepted for presentation in the Clinical Trials Symposium at The American Thoracic Society (ATS) 2024 International Conference on Monday, May 20, from 9:15-11:15 a.m. PDT.
AI Summary
Amgen has provided an update on its Phase 2a COURSE trial for TEZSPIRE® (tezepelumab-ekko) in patients with chronic obstructive pulmonary disease (COPD). The trial, which included patients with moderate to very severe COPD and a wide range of eosinophil levels, showed promising results. Overall, TEZSPIRE reduced the annualized rate of moderate or severe COPD exacerbations by 17% compared to placebo, with a more notable 37% reduction in patients having eosinophil counts of 150 cells/μL or more. These encouraging proof-of-concept data underline the potential of TEZSPIRE to address an unmet need in COPD treatment. The results have been accepted for presentation at the Clinical Trials Symposium during the ATS 2024 International Conference on May 20, from 9:15-11:15 a.m. PDT. Amgen is now actively planning Phase 3 development of TEZSPIRE in COPD.
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