Drugs / Tarlatamab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed small cell lung carcinoma 2 milestones | |||||
| Filed | China (NMPA) | — | small cell lung carcinoma | 2025-08-06 | “Achieved acceptance of BLA and priority review in China for the treatment of 3L+ small cell lung cancer (SCLC).” beonemedicines.com ↗ “Achieved acceptance of BLA in China for the treatment of 2L SCLC.” beonemedicines.com ↗ |
| Filed | US (FDA) | — | small cell lung carcinoma | 2023-12-13 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's Biologics License Application (BLA) for tarlatamab.” amgen.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Imdylltra | — | 2026-05-29 | europa.eu ↗ |
Trials 37
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT07531095 | Apr 2026 → May 2028 expected | small cell lung carcinoma | Amgen | Recruiting | No outcome recorded |
| Phase 1 | NCT07037758 | Sep 2025 → Mar 2028 expected | small cell lung carcinoma | Amgen | Recruiting | No outcome recorded |
| Phase 1 | NCT06898957 | May 2025 → Jun 2031 expected | small cell lung carcinoma | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06598306 | Oct 2024 → Apr 2027 expected | small cell lung carcinoma | Amgen | Recruiting | No outcome recorded |
| Phase 1 | NCT06551142 | Sep 2024 → Oct 2028 expected | neoplasm | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 1 | NCT05361395 | Aug 2022 → May 2030 expected | small cell lung carcinoma | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04885998 | Sep 2021 → Jul 2023 | small cell lung carcinoma | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT04702737 | Jun 2021 → Jul 2024 | prostate neuroendocrine neoplasm | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT03319940 | Dec 2017 → Dec 2026 expected | small cell lung carcinoma | Amgen | Active not recruiting | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07328490 | Apr 2026 | small cell lung carcinoma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT07243470 | Nov 2025 → Oct 2029 expected | central nervous system cancer, glioma | Centre Leon Berard | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06814496 | Sep 2025 → May 2030 expected | cervical cancer, cutaneous neuroendocrine carcinoma, esthesioneuroblastoma, glioblastoma +6 | University of Arizona | Recruiting | No outcome recorded |
| Phase 217 trials | ||||||
| Phase 2 | NCT07699237 | Nov 2026 → Jun 2031 expected | small cell lung carcinoma | University of Cologne | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07242547 | May 2026 → Jun 2030 expected | small cell lung carcinoma | Fundación GECP | Recruiting | No outcome recorded |
| Phase 2 | NCT07402343 | May 2026 → Feb 2029 expected | metastatic malignant neoplasm in the brain, small cell lung carcinoma | Maastricht University Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07203053 | Apr 2026 → Oct 2029 expected | small cell lung carcinoma | ETOP IBCSG Partners Foundation | Recruiting | No outcome recorded |
| Phase 2 | NCT07423585 | Mar 2026 → Dec 2027 expected | small cell lung carcinoma | Asrar Alahmadi | Recruiting | No outcome recorded |
| Phase 2 | NCT06816394 | Jan 2026 → Dec 2027 expected | small cell carcinoma | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07061080 | Dec 2025 → Sep 2026 | neuroendocrine carcinoma | Spanish Group for Research in Neuroendocrine Tumors | Terminated | No outcome recorded |
| Phase 2 | NCT06893783 | Sep 2025 → Apr 2029 expected | pancreatic endocrine carcinoma, prostate neuroendocrine neoplasm | Inkeun Park | Recruiting | No outcome recorded |
| Phase 2 | NCT06776250 | Aug 2025 → Mar 2028 expected | astrocytic tumor, oligodendroglial tumor | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT07111507 | Jul 2025 → Aug 2027 expected | metastatic prostate carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07016230 | Jul 2025 → May 2027 expected | small cell lung carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 2 | NCT06830694 | May 2025 → Mar 2027 expected | small cell lung carcinoma | Sehhoon Park | Recruiting | No outcome recorded |
| Phase 2 | NCT06788938 | Mar 2025 → Apr 2028 expected | neoplasm | Jonsson Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06745323 | Feb 2025 → Aug 2029 expected | small cell lung carcinoma | Amgen | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07803848 | Jan 2025 → Dec 2027 expected | small cell lung carcinoma | AIO-Studien-gGmbH | Recruiting | No outcome recorded |
| Phase 2 | NCT06502977 | Aug 2024 → Mar 2025 overdue | small cell lung carcinoma | Amgen | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05060016 | Dec 2021 → Dec 2026 expected | small cell lung carcinoma | Amgen | Active not recruiting | No outcome recorded |
| Phase 37 trials · 2 met primary | ||||||
| Phase 3 | NCT07637513 | Jan 2027 → Nov 2037 expected | small cell lung carcinoma | PrECOG, LLC. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07778316 | Aug 2026 → Sep 2027 expected | small cell lung carcinoma | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT06937905 | Feb 2026 → Feb 2029 expected | neuroendocrine carcinoma | French Cooperative Thoracic Intergroup | Recruiting | No outcome recorded |
| Phase 3 | NCT07005128 | Aug 2025 → Jan 2029 expected | small cell lung carcinoma | Amgen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06211036 | Jun 2024 → Jul 2027 expected | small cell lung carcinoma | Amgen | Active not recruiting | Met primary |
| Phase 3 | NCT06117774 | Feb 2024 → Apr 2030 expected | small cell lung carcinoma | Amgen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05740566 | May 2023 → Jan 2025 overdue | small cell lung carcinoma | Amgen | Active not recruiting | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT06064500 | — | small cell lung carcinoma | Amgen | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | Amgen | Regulatory FDA APPROVES REDUCED MONITORING TIME FOR FIRST TWO DOSES OF IMDELLTRA® amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved an update to the IMDELLTRA ® (tarlatamab-dlle) Prescribing Information that substantially reduces the recommended monitoring time for the first two doses of treatment in an appropriate healthcare setting. |
| 2026-09-08 | Alexion Pharmaceuticals, Inc. | Results Imfinzi plus Imdelltra demonstrated a statistically significant and highly clinically meaningful improvement in overall survival and progression-free survival in 1st-line extensive-stage small cell lung cancer astrazeneca.com ↗
Imfinzi plus tarlatamab also demonstrated a statistically significant and clinically meaningful improvement in the secondary endpoints of progression-free survival (PFS) and objective response rate. |
| 2026-09-08 | Amgen | Results IMDELLTRA® IN COMBINATION WITH IMFINZI® DEMONSTRATED LANDMARK IMPROVEMENT IN OVERALL SURVIVAL IN FIRST-LINE EXTENSIVE STAGE SMALL CELL LUNG CANCER amgen.com ↗
The study also demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and objective response rate (ORR) among patients treated with IMDELLTRA in combination with durvalumab. |
| 2026-06-01 | Amgen | Regulatory EUROPEAN COMMISSION APPROVES AMGEN'S IMDYLLTRA® FOR THE TREATMENT OF EXTENSIVE-STAGE SMALL CELL LUNG CANCER amgen.com ↗
Amgen (NASDAQ: AMGN ) today announced that the European Commission (EC) has granted marketing authorization for IMDYLLTRA® (tarlatamab) as a monotherapy to treat adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy. |
| 2025-11-19 | Amgen | Regulatory FDA GRANTS FULL APPROVAL TO AMGEN'S IMDELLTRA® IN EXTENSIVE STAGE SMALL CELL LUNG CANCER amgen.com ↗
The decision to convert IMDELLTRA's prior accelerated approval to a full approval is based on data from the global Phase 3 DeLLphi-304 study. |
| 2025-06-02 | Amgen | Results IMDELLTRA® SIGNIFICANTLY REDUCED RISK OF DEATH BY 40% IN SMALL CELL LUNG CANCER PATIENTS amgen.com ↗
At the planned interim analysis, DeLLphi-304 met its primary OS endpoint and key secondary progression-free survival (PFS) endpoint. |
| 2025-04-11 | Amgen | Results IMDELLTRA® DEMONSTRATED SUPERIOR OVERALL SURVIVAL IN SMALL CELL LUNG CANCER amgen.com ↗
IMDELLTRA demonstrated statistically significant and clinically meaningful improvement in overall survival (OS) compared to local standard-of-care (SOC) chemotherapy. |
| 2024-09-18 | Amgen | Results アムジェン社、ファースト・イン・クラスのタルラタマブ（遺伝子組換え）の小細胞肺がんに対する新たなデータをWCLC 2024にて発表 amgen.co.jp ↗
第Ⅱ相DeLLphi-301試験の延長追跡データから、プラチナ製剤を含む化学療法による前治療歴を有するES-SCLC患者において、タルラタマブの持続的な抗腫瘍効果と管理可能な安全性プロファイルが示されました。 |
| 2024-09-09 | Amgen | Results AMGEN PRESENTS NEW DATA FOR FIRST-IN-CLASS IMDELLTRA™ (TARLATAMAB-DLLE) IN SMALL CELL LUNG CANCER AT WCLC 2024 amgen.com ↗
DeLLphi-303 Study Results Show Potential for IMDELLTRA in Combination with a PD-L1 Inhibitor as First-Line Maintenance Therapy |
| 2024-05-28 | Amgen | Results AMGEN TO PRESENT INNOVATIVE RESEARCH FROM ITS ROBUST ONCOLOGY PORTFOLIO AT ASCO 2024 amgen.com ↗
Subgroup analysis of the Phase 2 DeLLphi-301 study demonstrated durable anticancer activity in relapsed/refractory small cell lung cancer (SCLC) regardless of the presence of treated, stable brain metastases at baseline. |
| 2024-05-16 | Amgen | Regulatory FDA APPROVES IMDELLTRA™ (TARLATAMAB-DLLE), THE FIRST AND ONLY T-CELL ENGAGER THERAPY FOR THE TREATMENT OF EXTENSIVE-STAGE SMALL CELL LUNG CANCER amgen.com ↗
Amgen (NASDAQ:AMGN) today 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. |
| 2023-12-13 | Amgen | Regulatory FDA GRANTS PRIORITY REVIEW TO AMGEN'S TARLATAMAB APPLICATION FOR ADVANCED SMALL CELL LUNG CANCER amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's Biologics License Application (BLA) for tarlatamab. |
| 2023-10-20 | Amgen | Results AMGEN PRESENTS NEW TARLATAMAB DATA IN SMALL CELL LUNG CANCER amgen.com ↗
With a median follow-up of 10.6 months, an intention-to-treat analysis that included 100 patients at the selected 10 mg dose for tarlatamab demonstrated an objective response rate (ORR; primary endpoint) of 40% (97.5% Confidence Interval (CI): 29, 52). |
| 2023-10-16 | Amgen | Results AMGEN TO PRESENT NEW RESEARCH FROM ONCOLOGY PORTFOLIO AND PIPELINE AT ESMO 2023 amgen.com ↗
Results From Phase 2 DeLLphi-301 Trial Highlight Potential of Tarlatamab, First BiTE in Patients With Previously Treated SCLC |
| 2023-08-03 | Amgen | Results AMGEN REPORTS SECOND QUARTER FINANCIAL RESULTS amgen.com ↗
Positive Top-Line Results for Tarlatamab in Small Cell Lung Cancer |
| 2023-06-01 | Amgen | Results AMGEN PRESENTS NEW SCIENTIFIC AND CLINICAL RESEARCH ACROSS ITS DIVERSE ONCOLOGY PORTFOLIO AND PIPELINE AT ASCO 2023 amgen.com ↗
Additional Analyses from DeLLphi-300 Highlight Safety and Clinical Efficacy of Tarlatamab, an Investigational First-in-Class BiTE ® Immunotherapy, in Patients with SCLC With Treated and Stable Brain Metastases |
| 2022-08-08 | Amgen | Results AMGEN PRESENTS NEW TARLATAMAB CLINICAL DATA AT WCLC 2022 amgen.com ↗
Tarlatamab delivered a confirmed ORR of 23% (confirmed and unconfirmed responses), a median duration of response of 13.0 months and a median overall survival (OS) of 13.2 months. |
| 2022-08-07 | Amgen | Results AMGEN DATA AT WCLC 2022 HIGHLIGHTS POTENTIAL TO DELIVER TRANSFORMATIVE MEDICINES FOR HISTORICALLY DIFFICULT-TO-TREAT LUNG CANCERS amgen.com ↗
Updated Phase 1 Tarlatamab Data Reinforce Potential of BiTE ® Therapy in Small Cell Lung Cancer |
| 2022-02-08 | Amgen | Results AMGEN OUTLINES GROWTH STRATEGY THROUGH 2030 AT VIRTUAL BUSINESS REVIEW amgen.com ↗
He then presented updated data from a Phase 1 study in which tarlatamab demonstrated significant evidence of anti-tumor activity and a preliminary median duration of confirmed response >1 year. |
All press releases naming this drug 20 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 39 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tarlatamab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06814496 ↗ |
| Known as | AMG 757 | “This is an open-label, single-arm, multi-center, phase 2 study that will evaluate efficacy and safety of tarlatamab (AMG 757) for the treatment of subjects with extrapulmonary...” NCT06893783 ↗3“Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differentiated Neuroendocrine Carcinomas...” NCT07016230 ↗ “Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Small Cell Lung Cancer Patients From...” NCT06830694 ↗ “Tarlatamab (AMG 757), a bispecific T-cell engager molecule” PMID 36689692 ↗ Jan 2023 |
| Known as | Imdelltra | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095292 ↗ |
| Known as | Tarlatamab-dlle | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095292 ↗ |
| Action | Deplete | “By targeting DLL3 using Tarlatamab, engagement of tumor antigen and CD3 lead to cytotoxic synapse formation, triggering the release of proinflammatory cytokines, perforin, and...” NCT06830694 ↗ |
| Modality | Protein / enzyme biologic | “Half-Life Extended (HLE) Bispecific T cell engager (BiTE®)” NCT03319940 ↗ |
| Route | Intravenous | “Tarlatamab will be administered as a short term intravenous (IV) infusion” NCT03319940 ↗ |
| Target | DLL3 | “targeting delta-like protein 3 (DLL3)” NCT03319940 ↗ |