FDA Grants Priority Review of sBLA for Datopotamab Deruxtecan
If the application is successful, the therapy will become the first-line treatment for patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.
Global biopharmaceutical company, AstraZeneca, has revealed, in a Feb 3, 2026 press release, that the supplemental Biologics License Application (sBLA) for datopotamab deruxtecan (Datroway), submitted with Daichii Sankyo, has been accepted and granted priority review by the U.S. FDA (1). Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) that was discovered by Daichii Sankyo and is being jointly developed and commercialized by Daichii Sankyo and AstraZeneca.
The sBLA has been accepted based on the results from a Phase III trial, TROPION-Breast02, which demonstrated that datopotamab deruxtecan provides a statistically significant and clinically meaningful improvement in median overall survival and a 43% reduction in risk of disease progression or death compared with chemotherapy (1). Additionally, datopotamab deruxtecan was found to have more robust and durable treatment responses compared with chemotherapy and was found to have a consistent safety profile with previous clinical trials in breast cancer.
“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,” said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, in a company press release (1). “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.”
The application is being review under Project Orbis — an initiative designed to bring effective cancer treatments to patients as early as possible. If the application is approved, the treatment will become the standard of care treatment for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
“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,” added Ken Takeshita, Global Head, R&D, Daiichi Sankyo, in the press release (1). “We are eager to work with the FDA to bring this much needed treatment option to patients with metastatic triple-negative breast cancer.”
Other regulatory submissions for the therapy in breast and lung cancer are underway globally.
Reference
AstraZeneca. Datroway Granted Priority Review in the U.S. as 1st-Line Treatment for Patients with Metastatic Triple-Negative Breast Cancer Who Are Not Candidates for Immunotherapy. Press Release, Feb. 3, 2026.