Amgen shares rise on tarlatamab update

14 December 2023
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Biotech major Amgen (Nasdaq: AMGN) has announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for the company's Biologics License Application (BLA) for tarlatamab.

The investigational delta-like ligand 3 (DLL3) targeting bispecific t-cell engager (BiTE) therapy is in development for the treatment of adult patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

"The FDA's Priority Review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC"If approved, tarlatamab would be the first BiTE therapy for a major solid tumor. The FDA action date for a decision is June 12, 2024.

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