Daiichi Sankyo’s Enhertu Gets Accelerated Approval for Breast Cancer

December 31, 2019

Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) has received the FDA’s accelerated approval status for treating adults with HER2-positive breast cancer.

The agency approved the drug for patients with unresectable or metastatic HER2-positive breast cancer who have already received two or more anti-HER2-based regimens.

The approval stemmed from a clinical trial of 184 female patients, 60.3 percent of which experienced some tumor shrinkage.

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