Datroway approved in the US for first-line triple-negative breast cancer after extending survival

Daiichi Sankyo/Datroway

The FDA approved Datroway for metastatic triple-negative breast cancer in patients who cannot receive PD-1/PD-L1 immunotherapy. In TROPION-Breast02, Datroway added five months of survival over chemotherapy, making it the only TROP2-directed conjugate to extend survival in this setting. It is Datroway's third US indication.

• 644 patients vs investigator's choice of chemotherapy.
• Overall survival HR 0.79 (+5.0 months, median about two years); progression-free survival HR 0.57.
• Response rate 64% vs 30%.
• Reviews under way in the EU, China and Japan and through Project Orbis.