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The treatment, an antibody-drug conjugate discovered by Daiichi Sankyo, previously received Breakthrough Therapy status.
March 9, 2026
By: Patrick Lavery
Content Marketing Editor
AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) received Priority Review in the U.S. from a supplemental Biologics License Application (sBLA). The FDA granted the Priority Review for treatment of adults with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Specifically, the indication is for such patients who have residual invasive disease following neoadjuvant HER2-targeted treatment. For this setting, Enhertu also received Breakthrough Th...
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