Pharma powerhouses AstraZeneca and Daiichi Sankyo have announced that the US FDA has accepted their supplemental Biologics License Application (sBLA) for Datroway (datopotamab deruxtecan) and granted it Priority Review for adults with unresectable or metastatic triple-negative breast cancer (TNBC).
Priority Review is reserved for treatments that could offer significant improvements over existing options, either through enhanced safety, efficacy, or patient compliance. The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA).
The sBLA is being reviewed through Project Orbis, an international initiative designed to accelerate access to oncology treatments by allowing concurrent submission and review among participating countries.
Roughly 70% of metastatic TNBC patients are ineligible for immunotherapy, leaving chemotherapy as the only approved first-line option.
Susan Galbraith, Executive Vice President of Oncology Haematology R&D at AstraZeneca, said: “Datroway is the only medicine to significantly improve overall survival compared to chemotherapy in this patient population as demonstrated in the TROPION-Breast02 trial – the results of which are even more striking considering the trial enrolled a subset of patients with highly aggressive disease.
"The Priority Review of our submission underscores the impact of these results and its review under Project Orbis signals a widely shared commitment to bringing Datroway to patients around the world as quickly as possible.”
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, added: "Datroway potentially could be the first medicine approved in the 1st-line setting to significantly extend overall survival and nearly double the time without disease progression or death compared to chemotherapy in patients with metastatic triple-negative breast cancer for whom immunotherapy was not an option. We are eager to work with the FDA to bring this much needed treatment option to patients with metastatic triple-negative breast cancer.”
The sBLA is supported by TROPION-Breast02 Phase III trial results, showing Datroway delivered a 5-month improvement in median overall survival and a 43% reduction in risk of disease progression or death compared with chemotherapy.
Datroway also showed stronger and longer-lasting responses, with an objective response rate of 62.5% and duration of response of 12.3 months, versus 29.3% and 7.1 months for chemotherapy.
