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 AstraZeneca, the therapy has been designed to deliver deruxtecan directly to HER2-positive cancer cells, improving specificity and reducing off-target effects when compared with conventional chemotherapy. "The approval of Enhertu underscores that this specifically engineered HER2 directed antibody drug conjugate is delivering on its intent to establish an important new treatment for patients with HER2-positive metastatic breast cancer," Antoine Yver, MD, executive vice president and global head of oncology research and development at Daiichi Sankyo, said in a press release. "Since the beginning of our clinical trial program four years ago, we have focused on the opportunity to transform the treatment l
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