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Enhertu approved in the US for gastric cancer
Enhertu approved in the US for gastric cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 9823L\n AstraZeneca PLC\n 18 January 2021\n \n \n \n 18 January 2021 07:00 GMT\n \n \n \n Enhertu\n \n \n approved in the US for the treatment of patients with\npreviously treated HER2-positive advanced gastric cancer\n \n \n \n \n \n \n First HER2-directed medicine approved for patients with gastric cancer in a decade\n \n \n \n \n \n AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)'s\n \n Enhertu\n \n (trastuzumab deruxtecan) has been approved \n in the US for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.\n \n \n \n In the US, gastric cancer is most frequently diagnosed in the advanced stage, with only approximately 5% of patients surviving beyond five years.1,2 Approximately one in five gastric cancers are HER2 positive.3\n \n \n \n The approval by the Food and Drug Administration (FDA) was based on the positive results from the randomised DESTINY-Gastric01 Phase II trial conducted in Japan and South Korea. In the trial, Enhertudemonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) and objective response rate (ORR) versus chemotherapy (irinotecan or paclitaxel) in patients with advanced gastric cancer or GEJ adenocarcinoma who had progressed on at least two or more prior regimens including trastuzumab plus a fluoropyrimidine- and platinum-based chemotherapy combination.4\n \n \n \n \n Ronan Kelly, MD, MBA, Director of the Charles A. Sammons Cancer Center and the W.W. Caruth, Jr. Chair of Immunology at Baylor University Medical Center, Dallas, Texas, US, said: \"Patients with metastatic HER2-positive gastric cancer with progression following 1st-line treatment have historically faced poor outcomes, including low response to treatment and rapid disease progression. This approval represents the first time a HER2-directed medicine has demonstrated a significant improvement in survival compared to chemotherapy following initial treatment in the metastatic setting, and it has the potential to become the new standard of care for this patient population.\"\n \n \n \n \n \n Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: \"Today'...