Datroway (datopotamab deruxtecan), jointly developed by Japanese healthcare company Daiichi Sankyo Co Ltd (TYO:4568) and British-Swedish biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (NYSE:AZN), has received European Union approval as a first-line monotherapy for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy, Daiichi Sankyo announced on Friday.

This approval is based on the phase 3 TROPION-Breast02 trial, in which Datroway demonstrated statistically significant and clinically meaningful improvements in overall survival and progression-free survival versus investigator's choice of chemotherapy.

Median overall survival was 23.7 months with Datroway, compared with 18.7 months for chemotherapy, representing a 5.0-month improvement. Datroway reduced the risk of disease progression or death by 43% compared to chemotherapy, while median progression-free survival was 10.8 months versus 5.6 months for chemotherapy.

The treatment achieved an objective response rate of 62.5%, compared with 29.3% for chemotherapy. Serious adverse reactions occurred in 17% of Datroway-treated patients, and one fatality was attributed to interstitial lung disease or pneumonitis.

Datroway is now approved for two breast cancer indications in the EU and is the only TROP2-directed antibody-drug conjugate approved in the region to demonstrate an overall survival benefit in the first-line setting. The treatment was approved in the United States in May 2026 for the same patient population, while additional regulatory reviews are underway in several international markets.