Core Viewpoint - Hutchison China MediTech Limited (HCM) announced that the new drug application for Savolitinib, intended for adult patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with MET gene amplification after failing at least two prior treatments, has been accepted by the National Medical Products Administration (NMPA) of China and granted priority review status [1] Group 1 - The new drug application is based on data from a single-arm, multi-center, open-label Phase II registration study conducted in China, which achieved the primary endpoint of objective response rate (ORR) assessed according to RECIST 1.1 [1] - The study details can be found on clinicaltrials.gov under registration number NCT04923932 [1] - Savolitinib was included in the NMPA's list of breakthrough therapies for this potential indication in 2023, recognizing it as a new treatment for serious diseases with significant advantages over existing therapies [1]
和黄医药宣布赛沃替尼 用于治疗伴有MET扩增的胃癌患者的中国新药上市申请获受理并获纳入优先审评