By Sabela Ojea
AstraZeneca said the U.S. Food and Drug Administration approved Datroway, a treatment for metastatic breast cancer developed in combination with Daiichi Sankyo.
The Anglo-Swedish drugmaker on Friday said that the approval is for adult breast cancer patients who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
The decision was driven by the results of the Tropion-Breast01 Phase III trial, which showed that Datroway reduced by 37% the risk of disease progression or death when compared to chemotherapy.
Additional regulatory submissions for Datroway in breast cancer are under review in the European Union, China and other regions.
Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix
(END) Dow Jones Newswires
January 17, 2025 18:29 ET (23:29 GMT)
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