20th Jan 2025 08:38
(Alliance News) - AstraZeneca PLC on Monday said Datroway has been approved in the US for patients with a type of breast cancer.
The Cambridge-based pharmaceuticals firm explained the final approval from the US Food & Drug Administration was based on results from the Tropion-Breast01 Phase III trial.
These showed a 37% reduction in the risk of disease progression or death versus chemotherapy.
The approval for Datroway, also known as Dato-DXd, covers patients with metastatic HR-positive, HER2-negative breast cancer.
The safety profile of Datroway was consistent with the known profile of this medicine with no new safety concerns identified, AstraZeneca noted.
Datroway is a specifically engineered TROP2-directed antibody drug conjugate discovered by Daiichi Sankyo Co Ltd and being jointly developed and commercialised with AstraZeneca.
Additional regulatory submissions for Datroway in breast cancer are under review in the EU, China and other regions.
Shares in AstraZeneca were 0.2% higher at 10,958.00 pence each in London on Monday. Daiichi Sankyo closed 8.2% higher at 4,417 each in Tokyo on Monday.
By Jeremy Cutler, Alliance News reporter
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