Amgen: FDA Approves Imdelltra For Extensive-Stage Small Cell Lung Cancer Treatment

(RTTNews) - Amgen (AMGN) said that the U.S. Food and Drug Administration approved Imdelltra or tarlatamab-dlle for the treatment of adult patients with extensive-stage small cell lung cancer or ES-SCLC with disease progression on or after platinum-based chemotherapy.

Imdelltra has received accelerated approval based on the encouraging response rate and duration of response observed in clinical studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s), the company said in a statement.

The Imdelltra label includes a Boxed Warning for cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), in addition to warnings and precautions for cytopenias, infections, hepatotoxicity, hypersensitivity, and embryo-fetal toxicity.

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