U.S. FDA approves AstraZeneca's Datroway for advanced breast cancer

The U.S. Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan-dlnk) for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

The regulatory milestone follows a formal Priority Review by the FDA.

Datroway, a specifically engineered TROP2-directed DXd antibody-drug conjugate (ADC), was discovered by Daiichi Sankyo Company and is being jointly developed and commercialized alongside AstraZeneca (NYSE:AZN).

TNBC is a highly aggressive subtype of breast cancer that lacks estrogen, progesterone, and HER2 receptors, severely limiting conventional targeted treatment options.

The current approval addresses a significant clinical population facing rapid disease progression where immunotherapy is inappropriate or ineffective.

The approval is supported by efficacy and safety data from the pivotal TROPION-Breast02 Phase 3 clinical trial, which were previously detailed at the 2025 European Society for Medical Oncology (ESMO) Congress and published in the peer-reviewed journal Annals of Oncology.

In the clinical trial, Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) compared to an investigator’s choice of standard chemotherapy.

Patients treated with the ADC achieved a median OS of 23.7 months, versus 18.7 months in the chemotherapy control arm, representing a 21% reduction in the risk of death.

Assessments by a blinded independent central review (BICR) showed that Datroway cut the risk of disease progression or death by 43% relative to chemotherapy.

The median progression-free survival (PFS) was nearly double that of the control group, reaching 10.8 months for Datroway patients compared to 5.6 months for those on chemotherapy.

Furthermore, the TROP2-directed ADC generated deeper tumor responses.

The confirmed objective response rate (ORR) stood at 64% in the Datroway arm, more than doubling the 30% response rate recorded in the chemotherapy cohort.

The expanded label marks the second global oncology block approval for the co-developed DXd ADC platform, following its established therapeutic precedent in HER2-positive malignancies.