Trastuzumab Deruxtecan Gets FDA Priority Review for Metastatic HER2-Positive Breast Cancer

Trastuzumab Deruxtecan Gets FDA Priority Review for Metastatic HER2-Positive Breast Cancer
The U.S. Food and Drug Administration (FDA) has granted priority review to the application seeking trastuzumab deruxtecan's (DS-8201) approval for the treatment of metastatic HER2-positive breast cancer. The agency has set a Prescription Drug User Fee Act action date for the second quarter of 2020. By then, it must decide whether to approve trastuzumab deruxtecan for this indication. Developed by AstraZeneca and Daiicho Sankyo, trastuzumab deruxtecan is an investigational antibody-drug conjugate composed of the anti-cancer HER2-targeting antibody trastuzumab bound to an investigational cancer-killing agent called deruxtecan (a derivative of exatecan). Once the antibody binds to a cell positive for HER2, it releases the toxic compound, killing the cancer cell without harming healthy cells. The FDA had previously granted fast track and
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