Datroway supplemental new drug application submitted in Japan for patients with metastatic triple negative breast cancer Who Are Not Candidates for Immunotherapy

Daiichi Sankyo

12 February 2026 - Based on results from TROPION-Breast02 showing Datroway significantly improved overall survival versus chemotherapy in this patient population.

Daiichi Sankyo has submitted a supplemental new drug application to Japan’s MHLW for Datroway (datopotamab deruxtecan) for the treatment of adult patients with hormone receptor negative and HER2 negative unresectable or recurrent breast cancer, a subtype commonly referred to as triple negative breast cancer.

Read Daiichi Sankyo press release

Michael Wonder

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Michael Wonder

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Medicine , Dossier , Registration , Japan