AstraZeneca: EU approves Enhertu for breast cancer
(CercleFinance.com) - AstraZeneca announces that Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy or who develop recurrent disease during or within six months of completing adjuvant chemotherapy.
For the record, Enhertu is an antibody-drug conjugate (ADC) jointly developed and marketed by AstraZeneca and Daiichi Sankyo.
The approval by the European Commission follows a positive opinion from the Committee for Medicinal Products for Human Use and is based on the results of a phase III trial showing that Enhertu reduced the risk of disease progression or death by 50% and increased overall survival by over 6 months compared to chemotherapy.
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