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The US Food and Drug Administration (FDA) has granted this a Prescription Drug User Fee Act date during the first quarter of 2025.

This BLA is based on results from the TROPION-Breast01 phase 3 trial, which demonstrated the drug’s statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy in patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who had previously been treated with endocrine based therapy and one systemic therapy. The trial is ongoing, with overall survival (OS) results currently immature.

Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, commented: “Despite marked progress in the treatment of HR-positive, HER2-negative breast cancer, most patients with advanced disease develop endocrine resistance and face the prospect of one or several lines of chemotherapy. If approved, datopotamab deruxtecan has the potential to provide these patients an efficacious and better tolerated alternative to conventional chemotherapy.”

Ken Takeshita MD, global head, R&D at Daiichi Sankyo, added: “The FDA’s acceptance of the BLA brings us closer to providing patients with previously treated HR-positive, HER2-negative breast cancer an alternative option to conventional chemotherapy earlier in the metastatic setting. Following our recently accepted application for advanced nonsquamous non-small cell lung cancer in the US, along with additional regulatory reviews underway in China, the EU, Japan and other regions, we are working swiftly to bring datopotamab deruxtecan as a potential new treatment option to patients around the world.”