By VETTAPHARMA reporter: Washington, D.C., February 3, 2026 – The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for DATROWAY® (datopotamab deruxtecan) as a first-line treatment for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not eligible for PD-1/PD-L1 inhibitor immunotherapy. This decision reflects the agency’s recognition of Datroway’s potential to provide meaningful treatment improvements in a patient population with limited options.
Priority Review is reserved for medicines that may offer significant improvements in safety or effectiveness over existing therapies. Under the Prescription Drug User Fee Act (PDUFA), the FDA’s target action date for its regulatory decision is anticipated during the second quarter of 2026.
The application is under review through Project Orbis, a collaborative international regulatory initiative designed to accelerate access to promising cancer treatments by enabling concurrent submissions and reviews among participating authorities.
Approximately 70% of patients with metastatic TNBC are not candidates for immunotherapy—either because their tumors do not express PD-L1 or due to other clinical factors—leaving chemotherapy as the only approved first-line treatment option for many.
According to the companies’ announcement, the sBLA is supported by data from the Phase III TROPION-Breast02 trial, in which Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) compared with investigator’s choice of chemotherapy (hazard ratio [HR] 0.79; 95% confidence interval [CI]: 0.64-0.98; p=0.0291). In the same study, Datroway showed a 43% reduction in the risk of disease progression or death (HR 0.57; 95% CI: 0.47-0.69; p<0.0001).
In addition to survival benefits, patients receiving Datroway experienced more robust and durable responses, with an objective response rate (ORR) of 62.5% and a duration of response (DoR) of 12.3 months, compared to an ORR of 29.3% and a DoR of 7.1 months with chemotherapy.
Susan Galbraith, Executive Vice President of Oncology Haematology R&D at AstraZeneca, highlighted that Datroway is “the only medicine to significantly improve overall survival compared to chemotherapy in this patient population as demonstrated in the TROPION-Breast02 trial,” noting the trial involved patients with aggressive disease.
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, added that Datroway “could be the first medicine approved in the first-line setting to significantly extend overall survival and nearly double the time without disease progression or death” for patients ineligible for immunotherapy.
If approved, Datroway may become a new standard of care for metastatic TNBC patients ineligible for immunotherapy, offering a much-needed alternative to traditional chemotherapy in a population facing historically poor prognoses.
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