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FDA Approves AstraZeneca, Daiichi Sankyo’s ENHERTU in Breast Cancer

Phase III trial showed ENHERTU reduced the risk of disease progression or death by 72% versus trastuzumab emtansine.

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By: Kristin Brooks

Managing Editor, Contract Pharma

AstraZeneca and Daiichi Sankyo’s ENHERTU (fam-trastuzumab deruxtecan-nxki), a specifically engineered HER2-directed antibody drug conjugate (ADC), has been approved by the U.S. FDA for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen and have developed disease recurrence during or within six months of completing therapy.   The approval was based on positive results from the DESTINY-Breast03 Phase III trial tha...

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