Afatinib is qualified for priority review in the treatment of non-small cell lung cancer

Source: Boehringer Ingelheim, 2017-10-11, announced today that the FDA of the United States has accepted its SNDA application for additional new drugs submitted to gilotinib, which is used for first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients with EGFR exon 21 (l861q), g719x or s768i alternative mutations The FDA also grants the drug priority review qualification Lung cancer is one of the top killer diseases According to the latest statistics, more than one third of new lung cancer patients in the world appear in China Lung cancer is the most common cancer in China, and it also causes the most deaths It is estimated that in 2015, there were about 730000 new lung cancer patients and 610000 lung cancer deaths in China Among them, non-small cell lung cancer accounts for the vast majority of lung cancer, and many NSCLC patients have EGFR mutations, which is particularly common in Asian patients It is estimated that 30% - 40% of lung cancer patients in Asia have this mutation, while less than 10% of NSCLC patients have EGFR rare mutations (l861q, g719x or s7681) The prognosis and survival of these patients are poor, they need new treatment to alleviate the disease As an ErbB family receptor inhibitor, gilotif can irreversibly block EGFR (ErbB1) and other related members of ErbB family These receptors play a key role in tumor growth and diffusion Therefore, the covalently irreversible binding of gilotif and its receptor can selectively block the ErbB family signal pathway, thus bringing good anti-cancer effect ▲ molecular structure formula of gilotif (picture source: Wikipedia) At present, gilotif has been approved in the United States, the European Union (giotrif ®) and many other countries for the first-line treatment of NSCLC patients with EGFR exon 19 deletion or exon 21 (L858R) mutation, as well as lung squamous cell carcinoma patients who make progress after platinum chemotherapy The submission of this supplementary new drug application is based on the results of a comprehensive analysis of three phase 3 clinical trials lux lung, which evaluated the efficacy of gilotif in patients with rare EGFR mutations (l861q, g719x or s768i) If approved, gilotif will be the first targeted treatment for this patient subgroup, providing the most extensive first-line treatment options for EGFR mutation positive NSCLC patients "The acceptance and priority review of SNDA applications indicate that our company will continue to work on further study of gilotif in areas with high unmet medical needs for these patients with few treatment options," said Dr Martina flammer, vice president of clinical development and medical affairs, bringer ingelham "If approved for this indication, gilotif will be EGFR Mutation positive NSCLC patients provide the most extensive first-line treatment options " We look forward to the good news in the future and hope that NSCLC patients with rare mutations can benefit from the drug.