— Datopotamab deruxtecan indicated for patients ineligible for immunotherapy

May 26, 2026

• 2 min read

The FDA on Friday approved datopotamab deruxtecan (Dato-DXd; Datroway) as a first-line option for unresectable or metastatic triple-negative breast cancer patients ineligible for immunotherapy.

Approval of the Trop2-directed antibody-drug conjugate was based on results of TROPION-Breast02, a phase III study that demonstrated improved survival outcomes compared with investigator's choice of chemotherapy (paclitaxel, nab-paclitaxel [Abraxane], capecitabine, eribulin, or carboplatin).