Japan’s Ministry of Health, Labour and Welfare has received a supplemental New Drug Application (sNDA) for DATROWAY for the treatment of adults with unresectable or recurrent hormone receptor-negative, HER2-negative breast cancer, commonly known as triple-negative breast cancer (TNBC).
The application, submitted by Daiichi Sankyo, seeks approval of DATROWAY as a first-line treatment for patients with metastatic TNBC who are not candidates for immunotherapy. If approved, the therapy could become the first TROP2-directed antibody drug conjugate (ADC) available in Japan in the first-line metastatic TNBC setting.
The filing is based on results from the global Phase 3 TROPION-Breast02 trial, presented at the 2025 European Society for Medical Oncology Congress. In the study, DATROWAY demonstrated statistically significant and clinically meaningful improvements in both overall survival and progression-free survival compared with investigator’s choice of chemotherapy in previously untreated patients with locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option.
TROPION-Breast02 enrolled 644 patients across sites in Africa, Asia, Europe, North America and South America. Participants included patients whose tumours did not express PD-L1, as well as those with PD-L1-positive disease who could not receive immunotherapy due to prior exposure, comorbidities or limited access.
The trial compared DATROWAY with standard chemotherapy options including paclitaxel, nab-paclitaxel, capecitabine, carboplatin and eribulin. The dual primary endpoints were progression-free survival, assessed by blinded independent central review, and overall survival.
Triple-negative breast cancer accounts for around 15% of breast cancer cases globally and is considered one of the most aggressive subtypes. It lacks expression of estrogen and progesterone receptors and does not overexpress HER2, limiting targeted treatment options. For patients with metastatic disease who are ineligible for immunotherapy—estimated to represent roughly 70% of cases in the first-line setting—chemotherapy remains the current standard of care.
DATROWAY is a specifically engineered TROP2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being developed and commercialised by the company in Japan. Additional regulatory submissions for DATROWAY in breast and lung cancer are ongoing in other markets.
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