AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo's Datroway (datopotamab deruxtecan) has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for use as a first-line treatment in adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

The CHMP based its opinion on results from the TROPION-Breast02 Phase III trial, which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology.

In the trial, Datroway showed a 5.0-month improvement in median overall survival compared to chemotherapy, with median overall survival of 23.7 months versus 18.7 months for chemotherapy patients. The drug reduced the risk of disease progression or death by 43% compared to chemotherapy. The objective response rate was 62.5% for Datroway versus 29.3% for chemotherapy.

Datroway was approved in the U.S. in May 2026 for the same indication. Regulatory reviews are also underway in China, Japan, Australia, Canada, Singapore, and Switzerland under Project Orbis.

Datroway is a TROP2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.