FDA Grants Traditional Approval to Imdelltra for Extensive-Stage SCLC

Originally published by our sister publication Clinical Oncology NewsBy Clinical Oncology News StaffThe FDA granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen) for adults with extensive-stage small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024.Efficacy was evaluated in DeLLphi-304 (ClinicalTrials.gov Identifier: NCT05740566), a multicenter, randomized, open-label t