The European Commission has approved Datroway (datopotamab deruxtecan), developed by AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo, as a first-line monotherapy for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

The approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use and is based on results from the TROPION-Breast02 Phase III trial, which were published in Annals of Oncology.

In the trial, Datroway showed a statistically significant 5.0-month improvement in median overall survival compared to chemotherapy, with median OS of 23.7 months versus 18.7 months for chemotherapy (HR 0.79; 95% CI 0.64-0.98; p=0.0291). The drug also reduced the risk of disease progression or death by 43% compared to chemotherapy (HR 0.57; 95% CI 0.47-0.69; p<0.0001). The objective response rate was 62.5% for Datroway compared to 29.3% for chemotherapy.

Dave Fredrickson, Executive Vice President of AstraZeneca's Oncology Haematology Business Unit, noted that more than 80,000 people in Europe are diagnosed with TNBC each year.

Ken Keller, Global Head of Oncology Business and President and CEO of Daiichi Sankyo, Inc., said Datroway is "the only TROP2-directed antibody drug conjugate approved in the EU that has demonstrated an overall survival benefit in the 1st-line setting" for metastatic TNBC patients.

Datroway has been included in the ESMO Clinical Practice Guidelines as a Category IA first-line treatment option for eligible patients and received a score of 4 out of 5 on the ESMO Magnitude of Clinical Benefit Scale. The drug was previously approved in the U.S. in May 2026 for the same indication, and regulatory reviews are underway in China, Japan, Australia, Canada, Singapore, and Switzerland.

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