Amgen Inc. — Imdylltra EMA EPAR public assessment report (EMEA/H/C/006451, 2026)
Amgen Inc. · 2026 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted a positive opinion for Amgen's Imdylltra (tarlatamab) for extensive-stage small cell lung cancer (ES-SCLC) after platinum-based chemotherapy. Tarlatamab, a bispecific T-cell engager, demonstrated significant improvements in overall survival, progression-free survival, and objective response rate compared to standard of care in clinical trials, particularly in patients with higher DLL3 expression. Its mechanism of action involves T-cell activation. The drug's pharmaceutical development, manufacturing, and stability are robust, with a 4-year shelf life. Non-clinical studies confirmed anti-tumor activity and safety. Pharmacokinetic analyses supported a 10 mg Q2W regimen due to comparable efficacy and improved tolerability. Common adverse events include cytokine release syndrome and ICANS, which are manageable. The overall benefit-risk balance for tarlatamab is considered positive.
Key findings — cited to the page
| Neutropenia (treatment-related grade 3 or higher) in tarlatamab group | 4.4 % | · p.140 |
| CRS (grade ≥3) in tarlatamab group | 1.2 % | · p.140 |
| Grade 3 or higher TEAEs in tarlatamab group | 54.0 % | · p.140 |
| Treatment-related grade 3 or higher TEAEs in SOC chemotherapy group | 62.3 % | · p.140 |
| CRS (all grades) in tarlatamab group | 56.3 % | · p.140 |
| CRS (grade ≥2) in tarlatamab group | 13.9 % | · p.140 |
| Overall TEAEs of any grade in tarlatamab group | 98.8 % | · p.140 |
| CRS (any grade) in tarlatamab group | 56.3 % | · p.140 |
| Grade 3 or higher TEAEs in SOC chemotherapy group | 79.9 % | · p.140 |
| Treatment-related grade 3 or higher TEAEs in tarlatamab group | 26.6 % | · p.140 |
| Lymphopenia (treatment-related grade 3 or higher) in tarlatamab group | 3.6 % | · p.140 |
| ICANS (grade ≥2) in tarlatamab group | 4.0 % | · p.140 |
Source: Amgen Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →