[good news] ivetinib maleate, the first third generation EGFR inhibitor in China, has entered the priority review and accelerated its listing process

August 9, 2018 / Meitong news agency / -- on August 9, the drug review center (CDE) of the State Food and Drug Administration issued a notice that ivetinib maleate independently developed by Hangzhou Essen Pharmaceutical Research Co., Ltd was included in the priority review procedure for the listing of new drugs Ivetinib is the first original third-generation EGFR targeting inhibitor in China, which is mainly used to treat non-small cell lung cancer with egfrt790m mutation positive It is one of the important achievements of the national "major new drug creation" science and technology major projects in the 12th Five Year Plan In September 2014, avidini was approved by CFDA of China and FDA of the United States at the same time, and its new drug listing application was undertaken by CDE on June 22, 2018 This time, ivetinib, as a major science and technology project of "major new drug creation" in the 13th five year plan, was included in the thirty first batch of priority review procedures by CDE The latest report released by the National Cancer Center this year shows that the incidence rate of lung cancer is about 781 thousand in China, and the incidence and mortality rate is the highest NSCLC accounts for 80% - 85% EGFR-TKI (epidermal growth factor receptor tyrosine kinase inhibitor) is a standard method for the first-line treatment of EGFR gene mutation NSCLC, which has been widely used in the field of lung cancer treatment However, there are a large number of patients with T790M drug-resistant mutation after treatment, which urgently needs a new generation of clinical treatment In the past three years, through the evaluation of efficacy and safety for a large number of patients with advanced drug-resistant lung cancer, avetinib has significant efficacy and safety for patients with advanced lung cancer with egfrt790m drug-resistant mutation At the same time, some of the clinical data of ivetinib have been reported at CSCO, ESMO and wclc successively, and the international response is warm At present, ivetinib has carried out international clinical research in 7 cancer centers in the United States, France, Spain and other countries As the first original third generation EGFR new anti lung cancer drug in China, ivetinib, if approved to market as soon as possible, will provide new treatment options for the majority of patients, solve the largest clinical need of cancer in China, and alleviate the heavy medical burden of patients.