Global Finance News
12 Feb 2026, 10:20
## Daiichi Sankyo Submits sNDA in Japan for DATROWAY in First-Line Metastatic TNBC
Tokyo, February 12, 2026 — Daiichi Sankyo announced it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare for DATROWAY (datopotamab deruxtecan) to treat adult patients with hormone receptor-negative, HER2-negative unresectable or recurrent breast cancer, commonly known as triple negative breast cancer (TNBC).
The filing is based on results from the phase 3 TROPION-Breast02 trial, where DATROWAY demonstrated statistically significant and clinically meaningful improvements in overall survival and progression-free survival compared to chemotherapy as a first-line treatment for metastatic TNBC patients who are not candidates for immunotherapy.
If approved, DATROWAY could become the first TROP2-directed antibody drug conjugate (ADC) available in Japan for first-line metastatic TNBC. Approximately 70% of patients in this setting are not eligible for immunotherapy, leaving chemotherapy as the only current first-line option.
DATROWAY is a TROP2-directed ADC developed using Daiichi Sankyo’s proprietary DXd technology platform. The company is also pursuing additional global regulatory submissions for DATROWAY in breast and lung cancers.
Source: Daiichi Sankyo press release, February 12, 2026.
Tokyo, February 12, 2026 — Daiichi Sankyo announced it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare for DATROWAY (datopotamab deruxtecan) to treat adult patients with hormone receptor-negative, HER2-negative unresectable or recurrent breast cancer, commonly known as triple negative breast cancer (TNBC).
The filing is based on results from the phase 3 TROPION-Breast02 trial, where DATROWAY demonstrated statistically significant and clinically meaningful improvements in overall survival and progression-free survival compared to chemotherapy as a first-line treatment for metastatic TNBC patients who are not candidates for immunotherapy.
If approved, DATROWAY could become the first TROP2-directed antibody drug conjugate (ADC) available in Japan for first-line metastatic TNBC. Approximately 70% of patients in this setting are not eligible for immunotherapy, leaving chemotherapy as the only current first-line option.
DATROWAY is a TROP2-directed ADC developed using Daiichi Sankyo’s proprietary DXd technology platform. The company is also pursuing additional global regulatory submissions for DATROWAY in breast and lung cancers.
Source: Daiichi Sankyo press release, February 12, 2026.