2 April 2024 - Application based on results from the TROPION-Breast01 Phase 3 trial.
Daiichi Sankyo and AstraZeneca’s biologics license application for datopotamab deruxtecan has been accepted in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior systemic therapy for unresectable or metastatic disease.