AMGN - FDA Gives Accelerated Approval To Amgen's Drug For Small Cell Lung Cancer Patients | Benzinga
Thursday, the FDA approved Amgen Inc’s (NASDAQ:AMGN) Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
Imdelltra has received accelerated approval based on the response rate and duration of response (DoR) observed in clinical studies.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).