FDA accepts breast cancer candidate trastuzumab deruxtecan for priority review

17 October 2019

The US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) submitted by Japan’s Daiichi Sankyo (TYO: 4568) and partner Anglo-Swedish pharm major AstraZeneca.

The Prescription Drug User Fee Act (PDUFA) date for trastuzumab deruxtecan, a HER2-targeting antibody drug conjugate (ADC) and potential new medicine for the treatment of HER2-positive metastatic breast cancer, is set for the second quarter of 2020.

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