Merus N.V. announced on November 5, 2024, that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the zenocutuzumab Biologics License Application (BLA). The new target action date is February 4, 2025.
The extension was granted to allow sufficient time for the FDA to review information recently submitted by Merus in response to a Chemistry, Manufacturing, and Controls (CMC) information request. The company confirmed that no additional clinical data were requested by the FDA.
This regulatory delay impacts the timeline for potential approval and commercialization of zenocutuzumab for NRG1+ non-small cell lung cancer and pancreatic cancer. Merus believes securing a commercialization partnership is an important step for bringing zenocutuzumab to patients, if approved.
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