AstraZeneca's Datroway Gets FDA Priority Review in TNBC

AstraZeneca and Daiichi Sankyo today announced that the FDA has accepted and granted Priority Review to the supplemental Biologics License Application for Datroway (datopotamab deruxtecan) in adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.

Preferential Treatment is accorded to medicines which would result in significant additions as compared to existing treatments.

The Prescription Drug User Fee Act action date of FDA is anticipated to be in the second quarter of 2026. Project Orbis is also going through the application and it enables the world to test oncology medicines simultaneously to help bring new options to the patients sooner.

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Approximately 70 percent of patients having TNBC metastases cannot receive immunotherapy and are also not eligible to receive any other treatment except chemotherapy which is the approved first-line treatment. Datroway seeks to fill this unfulfilled need.  

Susan Galbraith, executive vice president, oncology haematology R&D, AstraZeneca, said: “Datroway is the only medicine to significantly improve … the results of which are even more striking considering the trial enrolled a subset of patients with highly aggressive disease.”

Ken Takeshita, global head, R&D, Daiichi Sankyo, said: “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.”

Results of the phase III TROPION-Breast02 trial that demonstrated an increase in median overall survival by 5.0 months and a 43 percent likelihood of disease progression or death compared to chemotherapy support the use of the sBLA. Datroway also provided improved and more sustainable response rates and safety profile in line with previous studies. In case it is approved, it will transform the first-line care among a vast number of TNBC patients.