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Enhertu approved in the EU for breast cancer
Enhertu approved in the EU for breast cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 2821M\n AstraZeneca PLC\n 20 January 2021\n \n \n \n 20 January 2021 07:00 GMT\n \n \n \n Enhertu\n \n \n approved in the EU for the treatment\nof HER2-positive metastatic breast cancer\n \n \n \n \n \n \n Approval based on DESTINY-Breast01 Phase II trial which showed clinically meaningful and durable responses in patients with previously treated disease\n \n \n \n \n AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)'s Enhertu (trastuzumab deruxtecan) has been granted conditional approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.\n \n \n In Europe, approximately 531,000 cases of breast cancer in women are diagnosed annually, with an estimated one in five cases being HER2-positive.1-3 The impact of the disease is significant, with breast cancer responsible for more than 141,000 deaths per year in Europe.1\n \n \n \n \n The approval by the European Commission was based on positive results from the single-arm DESTINY-Breast01 Phase II trial, in which Enhertu showed clinically meaningful and durable antitumour activity in patients with HER2-positive metastatic breast cancer who had received two or more prior anti-HER2-based regimens.4 It follows the December 2020 recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency, which reviewed the application under its accelerated assessment procedure.\n \n \n \n \n Professor Fabrice André, Head of Research, Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif, France, said: \"One in five women with breast cancer have HER2-positive disease and those with previously treated metastatic disease often progress quickly. One of the biggest challenges in this setting has been identifying treatments that produce a durable response.\n \n The DESTINY-Breast01 trial showed a breadth, depth and durability of response not previously seen in this patient population.\"\n \n \n \n \n Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: \"Enhertu is already transforming outcomes for patients with HER2-positive metastatic breast cancer in the US and Japan, and thi...