Amgen gains early FDA approval for lung cancer drug Imdelltra

The US Food and Drug Administration has approved 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.

Developed by US biotech major Amgen (Nasdaq: AMGN), Imdelltra has received accelerated approval -  a month ahead of the June 12 FDA action date - based on the encouraging 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), Amgen noted.

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