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Enhertu designated gastric cancer BTD
Enhertu designated gastric cancer BTD.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n RNS Number : 4548M\n AstraZeneca PLC\n 11 May 2020\n \n \n \n 11 May 2020 07:00 BST\n \n \n \n Enhertu \n \n \n granted \n \n \n Breakthrough Therapy Designation\nin the US for\n \n \n HER2-positive metastatic gastric cancer\n \n \n \n \n \n \n Second US Breakthrough Therapy Designation for Enhertu\n \n \n \n \n \n AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)'s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.\n \n \n \n \n Gastric cancer is the third leading cause of cancer mortality \n with a five\n -year survival rate of 5% for metastatic disease.1,2 Approximately one in five gastric cancers are considered HER2 positive.3,4\n \n \n \n \n \n The Food and Drug Administration's (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to have shown encouraging early clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.\n \n \n \n \n José Baselga, Executive Vice President, R&D Oncology, said: \"Current therapy options are limited for patients with HER2-positive metastatic gastric cancer and for those who relapse, there are no approved HER2-targeted medicines. We look forward to working with the FDA to further explore the potential of Enhertu to become an important new treatment and the first antibody drug conjugate for this devastating disease.\"\n \n Gilles Gallant, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo, said: \"DESTINY-Gastric01 represents the first randomised trial of Enhertu to demonstrate clinically meaningful and statistically significant results, including objective response and survival increases compared to physician's choice of chemotherapy. We are thrilled that the FDA has granted Enhertu a second Breakthrough Therapy Designation.\"\n \n \n The FDA granted BTD based on data from the registrational Phase II DESTINY...