Drugs / Tarlatamab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Imdylltra | — | 2026-05-29 | europa.eu ↗ |
Trials 35 · a red edge is where a trial was stopped
| 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 → Aug 2028 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| Phase 1/2 | NCT07328490 | Apr 2026 | small cell lung carcinoma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| 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 216 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 | NCT07061080 | Dec 2025 → Dec 2028 expected | neuroendocrine carcinoma | Spanish Group for Research in Neuroendocrine Tumors | Recruiting | 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 → Apr 2027 expected | medullary thyroid gland carcinoma, small cell lung carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 2 | NCT06816394 | May 2025 → Dec 2027 expected | small cell carcinoma | National Taiwan University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06830694 | May 2025 → Mar 2027 expected | small cell lung carcinoma | Se-Hoon Lee | Recruiting | No outcome recorded |
| Phase 2 | NCT06788938 | Mar 2025 → Apr 2028 expected | neoplasm | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06745323 | Feb 2025 → Feb 2029 expected | small cell lung carcinoma | Amgen | Active not 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 36 trials | ||||||
| Phase 3 | NCT07637513 | Jan 2027 → Nov 2037 expected | small cell lung carcinoma | PrECOG, LLC. | Not yet 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 | Recruiting | No outcome recorded |
| Phase 3 | NCT06211036 | Jun 2024 → Jul 2027 expected | small cell lung carcinoma | Amgen | Active not recruiting | No outcome recorded |
| 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 | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06064500 | — | small cell lung carcinoma | Amgen | Approved for marketing | No outcome recorded |
Press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-11-19 | Amgen | FDA GRANTS FULL APPROVAL TO AMGEN'S IMDELLTRA® IN EXTENSIVE STAGE SMALL CELL LUNG CANCER amgen.com ↗ |
| 2025-06-02 | Amgen | IMDELLTRA® SIGNIFICANTLY REDUCED RISK OF DEATH BY 40% IN SMALL CELL LUNG CANCER PATIENTS amgen.com ↗ |
| 2025-04-11 | Amgen | IMDELLTRA® DEMONSTRATED SUPERIOR OVERALL SURVIVAL IN SMALL CELL LUNG CANCER amgen.com ↗ |
| 2024-09-09 | Amgen | AMGEN PRESENTS NEW DATA FOR FIRST-IN-CLASS IMDELLTRA™ (TARLATAMAB-DLLE) IN SMALL CELL LUNG CANCER AT WCLC 2024 amgen.com ↗ |
| 2024-05-16 | Amgen | 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 ↗ |
| 2023-12-13 | Amgen | FDA GRANTS PRIORITY REVIEW TO AMGEN'S TARLATAMAB APPLICATION FOR ADVANCED SMALL CELL LUNG CANCER amgen.com ↗ |
| 2023-10-20 | Amgen | AMGEN PRESENTS NEW TARLATAMAB DATA IN SMALL CELL LUNG CANCER amgen.com ↗ |
| 2022-08-08 | Amgen | AMGEN PRESENTS NEW TARLATAMAB CLINICAL DATA AT WCLC 2022 amgen.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tarlatamab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06937905 ↗34 |
| 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 ↗ “Tarlatamab (AMG757), bispecific t-cell engager (BiTE), designed to engage DLL3 on SCLC and CD3 on T-cell” 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 | “leading to T cell-mediated tumor lysis” NCT07328490 ↗ |
| 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 ↗ |