AstraZeneca and Daiichi Sankyo's Datroway (Dato-DXd) Earns CHMP Recommendation for First-Line Metastatic Triple-Negative Breast Cancer

AstraZeneca and Daiichi Sankyo's Datroway (Dato-DXd) Earns CHMP Recommendation for First-Line Metastatic Triple-Negative Breast Cancer

On June 26, 2026, AstraZeneca and Daiichi Sankyo announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Datroway (datopotamab deruxtecan). The recommendation is for Datroway 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.

If formally approved by the European Commission, Datroway has the potential to become the first TROP2-directed antibody-drug conjugate (ADC) in the European Union with a demonstrated overall survival (OS) benefit in the first-line setting.¹

The positive opinion is based on results from the pivotal TROPION-Breast02 Phase III trial, which demonstrated:

• Survival Benefit: Datroway achieved a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) compared to traditional investigator's choice of chemotherapy (23.7 months vs. 18.7 months; hazard ratio [HR] 0.79; p=0.0291).
• Progression-Free Survival: Datroway reduced the risk of disease progression or death by 43% compared to chemotherapy (HR 0.57; p<0.0001) as determined by blinded independent central review.
• Response Rates: The objective response rate (ORR) was more than doubled under Datroway treatment, reaching 62.5% compared to 29.3% in the chemotherapy arm.
• Safety: The safety profile was consistent with prior clinical trials, showing manageable toxicities.

TNBC is a highly aggressive form of breast cancer representing roughly 15% of all breast cancer cases, with a historically poor prognosis (median overall survival of just 12 to 18 months). For the approximately 70% of patients whose tumors do not express PD-L1 or who are otherwise not candidates for immunotherapy, traditional chemotherapy was the only standard first-line option prior to the emergence of Datroway.

Datroway was previously approved by the U.S. FDA for this indication in May 2026, and additional regulatory reviews are currently underway in China, Japan, and other countries via Project Orbis.