FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer
Amgen's Imdelltra gains traditional FDA approval for adults with ES-SCLC that progressed after platinum-based chemotherapy.
The Food and Drug Administration granted traditional approval to tarlatamab-dlle, sold as Imdelltra by Amgen Inc., on November 19, 2025. The approval covers adults with extensive stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy.1
The FDA record also notes that tarlatamab-dlle previously received accelerated approval1, though the document does not specify the date of that earlier accelerated approval or detail the clinical data that supported either approval decision.
Readers should note that the source document provided for this report is incomplete, cutting off after the reference to the drug's accelerated approval. Additional details on trial results, dosing, or further regulatory context from the FDA's full announcement are not available in the material reviewed for this report.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.