Imdylltra
Oncology· 607 cited findings· 1 source document
Company: Amgen Inc. →
What the regulatory reviews say
Imdylltra (tarlatamab) is a new active substance designated as an orphan medicinal product (EU/3/23/2876, 12 January 2024) with an ATC code of L01FX33. The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on 26 March 2026. The finished product has a shelf life of 4 years.
In a study involving 509 subjects (254 in the tarlatamab arm and 255 in the Standard of Care arm), tarlatamab demonstrated an overall survival (OS) of 13.6 months compared to 8.3 months for SOC chemotherapy, with an overall survival Hazard Ratio of 0.599. Progression-free survival (PFS) was 4.2 months for tarlatamab versus 3.2 months for SOC chemotherapy. For patients without any subsequent therapy, the Hazard Ratio for OS (Tarlatamab/Standard of Care) was 0.427 (95% CI: 0.307, 0.595), with a median OS for Standard of Care of 4.8 months.
The median tarlatamab treatment duration was 18.21 weeks. Overall treatment-emergent adverse events (TEAEs) of any grade in the tarlatamab group were 98.8%, with 56.3% experiencing Cytokine Release Syndrome (CRS) of any grade. Grade 3 or higher TEAEs occurred in 54.0% of the tarlatamab group, compared to 79.9% in the SOC chemotherapy group.
Key figures — cited to the source page
| Overall survival (median months) | 13.6 | Amgen Inc. — Imdylltra EMA EPAR public assessment report (EM, p.141 |
| Overall survival (median months) for SOC chemotherapy | 8.3 | Amgen Inc. — Imdylltra EMA EPAR public assessment report (EM, p.141 |
| Overall survival Hazard ratio | 0.599 | Amgen Inc. — Imdylltra EMA EPAR public assessment report (EM, p.141 |
| Hazard Ratio for OS (Tarlatamab/Standard of Care) in patients without any subsequent therapy | 0.427 | Amgen Inc. — Imdylltra EMA EPAR public assessment report (EM, p.82 |
| 95% CI for Hazard Ratio for OS (Tarlatamab/Standard of Care) in patients without any subsequent therapy | 0.307, 0.595 | Amgen Inc. — Imdylltra EMA EPAR public assessment report (EM, p.82 |
| CRS (any grade) in tarlatamab group | 56.3 | Amgen Inc. — Imdylltra EMA EPAR public assessment report (EM, p.140 |
| Grade 3 or higher TEAEs in tarlatamab group | 54.0 | Amgen Inc. — Imdylltra EMA EPAR public assessment report (EM, p.140 |
| CHMP positive opinion date | 26 March 2026 | Amgen Inc. — Imdylltra EMA EPAR public assessment report (EM, p.11 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.