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Enhertu approved in EU for gastric cancer
Enhertu approved in EU for gastric cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n 19 December 2022 07:15 GMT\n \n \n \n \n \n \n \n \n Enhertu\n \n \n approved in the EU for patients with previously treated HER2-positive advanced gastric cancer\n \n \n \n \n \n \n First HER2-directed medicine to be approved for gastric cancer in the EU\n \n \n in more than a decade\n \n \n \n \n \n Based on DESTINY-Gastric02 and DESTINY-Gastric01 where AstraZeneca and\n \n \n Daiichi Sankyo's Enhertu demonstrated clinically meaningful efficacy\n \n \n \n \n \n AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.\n \n \n \n \n \n \n Enhertu\n \n is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.\n \n \n \n \n \n The approval by the European Commission follows the\n \n positive opinion\n of the Committee for Medicinal Products for Human Use in November 2022 and is based on results from the\n DESTINY-Gastric02 and DESTINY-Gastric01 Phase II trials.\n \n \n \n \n \n \n In DESTINY-Gastric02, which enrolled\n patients from North America and Europe,\n treatment with Enhertu resulted in a confirmed objective response rate (ORR) of 41.8% as assessed by independent central review (ICR). Median duration of response (DoR) was 8.1 months.\n \n \n \n \n \n In DESTINY-Gastric01, which enrolled patients from Japan and South Korea, treatment with Enhertu resulted in a confirmed ORR\n of 40.5% versus 11.3% with chemotherapy (irinotecan or paclitaxel) as assessed by ICR. The median DoR was 11.3 months with Enhertu versus 3.9 months with chemotherapy. P\n atients treated with Enhertu had a 41% reduction in the risk of death versus patients treated with chemotherapy (based on a hazard ratio of 0.59; 95% confidence interval: 0.39-0.88; p=0.0097) with a median overall survival (OS) of 12.5 months versus 8.4 months.\n \n \n \n \n \n Approximately 136,000 cases of gastric cancer are diagnosed annually in Europe, where it represents the sixth leading cause of cancer death.1,2 Gastric cancer is typically diagnosed in the advanced stage. Even when th...