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Home » AstraZeneca’s Enhertu Snags EU Approval for Metastatic Breast Cancer
AstraZeneca’s Enhertu Snags EU Approval for Metastatic Breast Cancer
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AstraZeneca and Daiichi Sankyo have announced that their drug Enhertu (trastuzumab deruxtecan) has received conditional approval in the European Union to treat adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens.
The approval was based on positive results from a phase 2 trial, in which Enhertu showed clinically meaningful anti-tumor activity in patients with HER2-positive metastatic breast cancer who had received two or more prior anti-HER2-based treatments.
The FDA granted Enhertu an Accelerated Approval for the same indication in December 2019.
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