FDA Approves Datroway for Unresectable or Metastatic, HR-positive, HER2-negative Breast Cancer

The FDA has approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo), a Trop-2−directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH−) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Efficacy was evaluated in TROPION-Breast01