Group 1 - The core point of the article is that Ailis has updated the registration status of its self-developed small molecule targeted drug, Fumetinin Mesylate Tablets, for the treatment of EGFR exon 20 insertion mutation NSCLC to "Approval Completed - Awaiting Certification" [2] - The indication is for adult patients with locally advanced or metastatic NSCLC who have progressed on or are intolerant to prior platinum-based chemotherapy and have confirmed EGFR exon 20 insertion mutations [2] - Phase II clinical trials showed an overall response rate (ORR) of 44.3%, a median progression-free survival (PFS) of 8.3 months, and a median overall survival (OS) of 22.9 months, indicating potential for expanding patient coverage and increasing sales [2]
艾力斯:关于甲磺酸伏美替尼片EGFR 20号外显子插入突变NSCLC二线治疗适应症药品注册进展的公告