Enhertu Gets FDA Approval for Treatment of Advanced HER2-positive Breast Cancer

Enhertu Gets FDA Approval for Treatment of Advanced HER2-positive Breast Cancer
The U.S. Food and Drug Administration (FDA) approved Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with inoperable or metastatic HER2-positive breast cancer who have received at least two prior anti-HER2-based regimens after their cancer had spread. This accelerated approval comes just a few months after the agency agreed to review the application, under priority review. The medication should become available to patients in the U.S. in the coming weeks. Accelerated approval is a form of conditional approval given to a medication that addresses an unmet need in a serious medical condition, providing it has shown benefits on surrogate or interim measures in a clinical trial. Enhertu’s continued use, and full approval, requires further verification and description of clinical benefit in a confirmatory study. Enhertu, formerly known as DS-8201, is an antibody-drug conjugate consisting of the anti-HER2 antibody trastuzumab bound to the cancer-killing agent deruxtecan (a derivative of exatecan). Jointly developed by Daiichi Sankyo and
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