DATROWAY Supplemental New Drug Application submitted in Japan for patients with metastatic triple negative breast cancer who are not candidates for immunotherapy

CAR-T Digest - August 2020

Weekly Digest - February 2026

12 February 2026: DATROWAY Supplemental New Drug Application submitted in Japan for patients with metastatic triple negative breast cancer who are not candidates for immunotherapy

Daiichi Sankyo has submitted a supplemental New Drug Application to Japan’s Ministry of Health, Labour and Welfare for DATROWAY (datopotamab deruxtecan) as a first-line treatment for adults with unresectable or recurrent triple negative breast cancer who are not candidates for immunotherapy
The filing is supported by results from the Phase 3 TROPION-Breast02 trial, presented at the 2025 ESMO Congress, where DATROWAY demonstrated statistically significant and clinically meaningful improvements in both overall survival and progression-free survival compared with investigator’s choice of chemotherapy
Metastatic triple negative breast cancer remains one of the most aggressive subtypes of breast cancer, with limited treatment options, particularly for the approximately 70% of patients who are not eligible for immunotherapy in the first-line setting
If approved, DATROWAY would become the first TROP2-directed antibody–drug conjugate available in Japan for first-line metastatic triple negative breast cancer, potentially establishing a new standard of care in this high-unmet-need population
The submission in Japan adds to a growing global regulatory effort for DATROWAY, with additional applications underway in breast and lung cancer indications across multiple regions