www.fdanews.com/articles/195329-daiichi-sankyos-enhertu-gets-accelerated-approval-for-breast-cancer
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.