AstraZeneca (AZN) said Monday the US Food and Drug Administration has accepted its supplemental Biologics License Application for Imfinzi, or durvaluma, and granted it priority review.
The application seeks approval for the treatment of patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers, the company said.
The FDA's Priority Review designation is granted to drugs that could offer significant improvements in safety or efficacy compared to existing treatments, it added.
AstraZeneca said the Prescription Drug User Fee Act (PDUFA) action date for the FDA's decision is expected in the fourth quarter of 2025.
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