Posted by Michael Wonder on 17 Jan 2025
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR positive, HER2 negative breast cancer
17 January 2025 - Today, the FDA 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 positive, human epidermal growth factor receptor 2 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, a multi-centre, open-label, randomised trial.
