Amgen Inc. — Imdelltra FDA Review (NDA/BLA 761344, 2026)
Amgen Inc. · 2026 · FDA Review (Drugs@FDA) · company profile →
Report summary
Amgen's Imdelltra (tarlatamab-dlle) received FDA traditional approval on November 19, 2025, for extensive stage small cell lung cancer (ES-SCLC) after platinum-based chemotherapy, converting its accelerated approval. This approval was based on the DeLLphi-304 study, which demonstrated significant improvements in overall survival (OS) (HR 0.60, median OS 13.6 vs 8.3 months) and progression-free survival (PFS) compared to standard of care. Key safety concerns include cytokine release syndrome (CRS) and neurologic toxicity, including ICANS, which were observed in clinical trials. The 10 mg Q2W regimen was selected for its comparable efficacy and improved tolerability. The FDA's multidisciplinary review confirmed the drug's efficacy and safety profile, fulfilling postmarketing requirements.
Key findings — cited to the page
| Grade >= 2 CRS after Cycle 1 Day 1 | 24 % | IMDELLTRA · p.26 |
| Grade 4 CRS incidence | 0.2 % | IMDELLTRA · p.26 |
| Grade 3 CRS | 1.2 % | Study 20210004 · p.338 |
| Recurrent Grade 2 CRS incidence | 3.4 % | IMDELLTRA · p.26 |
| Grade 2 CRS incidence | 15 % | IMDELLTRA · p.26 |
| Grade 3 CRS incidence | 1.7 % | IMDELLTRA · p.26 |
| Grade 3+ TEAEs (tarlatamab) | 54 % | Study 20210004 · p.338 |
| Grade 3+ TEAEs (Standard of Care) | 80 % | Study 20210004 · p.338 |
| Grade 3+ ICANS | 1 | Study 20210004 · p.339 |
| Recurrent Grade 1 CRS incidence | 20 % | IMDELLTRA · p.26 |
| Grade 1 CRS incidence | 39 % | IMDELLTRA · p.26 |
| Grade >= 2 CRS after Cycle 1 Day 8 | 8 % | IMDELLTRA · p.26 |
Source: Amgen Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →