FDA approves Datroway: a novel therapy for HR-positive, HER2-negative metastatic breast cancer

The Food and Drug Administration (FDA) has approved datopotamab deruxtecan (Datroway) for the treatment of unresectable or metastatic HR-positive, HER2-negative breast cancer. This antibody-drug conjugate comprises a monoclonal antibody (mAb) that targets TROP2, a cytotoxic agent DXd, and a linker. The mAb binds to TROP2 on cancer cells, facilitating internalization, after which DXd is released, inducing cell death. In the TROPION-Breast01 trial, datopotamab deruxtecan demonstrated superiority over conventional chemotherapy. It provides a promising alternative for patients who have failed prior endocrine or chemotherapy, offering enhanced efficacy than traditional treatments. However, additional studies are required to thoroughly assess the drug's safety and efficacy, as well as to establish the most current information regarding its optimal dosage and administration guidelines.