Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking approval of Datroway (datopotamab deruxtecan) for the treatment of adult patients with hormone receptor-negative and HER2-negative unresectable or recurrent breast cancer, commonly known as Triple Negative Breast Cancer (TNBC).

The application is supported by data from the global phase III TROPION-Breast02 trial, presented at the 2025 European Society for Medical Oncology (ESMO) Congress. In the study, Datroway demonstrated significant and clinically meaningful improvements in both Overall Survival (OS) and Progression-Free Survival (PFS) compared to investigator’s choice of chemotherapy as first-line therapy for patients with metastatic TNBC who were not eligible for immunotherapy.

TROPION-Breast02 is a multicentre, randomised, open-label phase III trial evaluating Datroway versus standard chemotherapy options including paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin. The study enrolled 644 patients across Africa, Asia, Europe, North America and South America. Dual primary endpoints were PFS assessed by blinded independent central review and OS, with secondary endpoints including objective response rate, duration of response, disease control rate, pharmacokinetics and safety.

Approximately 70 percent of patients with metastatic TNBC are not candidates for immunotherapy and rely on chemotherapy as first-line treatment. TNBC accounts for about 15 percent of all breast cancer cases globally, with around 345,000 diagnoses annually. In Japan, an estimated 12,700 cases were diagnosed in 2024. Metastatic TNBC is associated with poor prognosis, with median overall survival ranging from 12 to 18 months.

Datroway is a TROP2-directed Antibody Drug Conjugate (ADC) developed using Daiichi Sankyo’s proprietary DXd ADC technology. It is currently approved in more than 40 countries for hormone receptor-positive, HER2-negative breast cancer following prior endocrine-based therapy and chemotherapy. The drug is also approved in the US and Russia for certain patients with EGFR-mutated non-small cell lung cancer.

Additional regulatory submissions for Datroway in breast and lung cancers are underway globally.