Amgen granted Priority Review by FDA for BLA for tarlatamab

Amgen announced that the U.S. Food and Drug Administration has accepted and granted Priority Review for the company’s Biologics License Application for tarlatamab. Tarlatamab is a potential first-in-class, investigational delta-like ligand 3 targeting Bispecific T-cell Engager therapy for the treatment of adult patients with advanced small cell lung cancer with disease progression on or after platinum-based chemotherapy. Based on the Priority Review designation, the Prescription Drug User Fee Action date for tarlatamab is June 12, 2024.