Imdelltra

Drug

Also known as: IMDELLTRA

Drug Profile

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\

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