
LONDON (dpa-AFX) - AstraZeneca and Daiichi Sankyo's Biologics License Application (BLA) for datopotamab deruxtecan has been granted Priority Review in the US for the treatment of adults with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), AstraZeneca said in a statement on Monday.
The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is expected during the third quarter of 2025.
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