THOUSAND OAKS (dpa-AFX) - 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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