AstraZeneca’s Datroway granted Priority Review for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy

AstraZeneca and Daiichi Sankyo’s SBLA for Datroway has now been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.

The FDA has recently granted Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.

Note that the sBLA is being reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. This initiative is designed to bring effective cancer treatments to patients as early as possible.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, 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, 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 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.”

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Related Topics and Keywords

1st-line treatment, AstraZeneca, breast cancer, Datroway, metastatic triple-negative breast cancer