Imdelltra (tarlatamab-dlle) is a DLL3-directed bispecific T-cell engager immunotherapy for adults with extensive-stage small cell lung cancer after platinum-based chemotherapy progression. It first received FDA accelerated approval in 2024 and was converted to traditional full approval in November 2025. The treatment requires specialized step-up dosing and monitoring for cytokine release syndrome and neurologic toxicities.
- Drug Class
- DLL3-directed bispecific T-cell engager immunotherapy
- Approval Status
-
FDA traditional approval granted November 19, 2025 (following accelerated approval in 2024)
Brand Names
- Imdelltra
- tarlatamab-dlle
Indications
- \Adults with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy\