First domestic MET inhibitor "Volitini" listing application by CDE

On June 6, CDE's official website showed that the application for listing of the "Volitini Tablet" declared by Shanghai Hutchison Whampoa Pharmaceuticals was sponsored by CDE (acceptance number: CXHS200012/13) for the treatment of patients with non-small cell lung cancer (NSCLC) with interstitial epithelial conversion factor (MET) exothes 14 jumpThis application for a new drug is based on an open-label Phase II Registration Data Support (NCT02897479)The latest data, presented at the 2020 ASCO Conference, included 70 cases of MET14-mutant non-small cell lung cancer, of which 57.1% were lung adenocarcinoma, up to 35.7% were lung sarcoma-like cancer (PSC), and up to 22% combined with brain metastasisIn stages, 92.9% of patients are in stage IV and 60% are treatedAll patients are treated with Volitinib (600 mg (50 kg or more); The main study endpoint is ORRThe results showed that in 61 patients with an evaluative efficacy, the overall effectiveness rate was 47.5% and the disease control rate was 93.4%Median PFS is 6.8 months (first in a combined high proportion of PSC patients, the overall PFS is more than half a year)The most common adverse reactions include peripheral edema, nausea, elevated AST/ALT levels, vomiting, and low proteinuriaThe incidence of MET14 exon jump mutation in the abnormally driven gene of lung cancer is 3% to 4% in lung adenocarcinoma, and met gene mutation is the cause of drug resistance in many tumors, and the prognosis is poor in lung cancer patients with MET14 exoon jump mutationPatients with this mutation are insensitive to chemotherapy and the treatment is not idealLung sarcoma-like cancer (PSC) is a rare type of lung cancer with poor prognosis, psC is more prone to invasion and metastasis than other NSCLCs, and MET Exon14 plus in PSC can be as high as 31.8 percent, the emergence of Volitinib brings new hope to such patients, and we hope that the drug can be approved early and bring new treatments to this type of patient in the country.