CNDA approves Roche Alecensa for treatment of patients with advanced non-small cell lung cancer

recently, SwissPharmaceutical(Roche) announced that China's NationalPharmaceutical(CNDA) has approved Alecensa (Alectinib, Allotinib) as a single-drug therapy for patients with mesothelioma kinase (ALK) positive for advanced non-small cell lung cancer (NSCLC)it's worth noting that Alecensa was approved only eight months and nine months later than the European Medicines Agency (EMA) and the U.SFood and(
FDA
() first-line approvalabout AlecensaAlecensa is a new small molecule tyrosine kinase inhibitor (TKI) that targets ALK, in the United States and the European Union, and received accelerated and conditional approval in December 2015 and February 2017, respectively, as a single-drug therapy for second-stage treatment of adult patients with advanced NSLC of ALK who have been treated with Xalkoriin addition,, Alecensa was approved by the United States and the European Union in November 2017 and December 2017 as a single-drug therapy for first-line treatment of ALK-positive NSCLCrelated studies
ALEX study is a randomized, multicenter, open label study conducted in 303 patients with a newborn ALK-positive NSCNC, designed to compare the efficacy and safety of Alecensa and Xalkori for first-line therapyresults show that, compared to Xalkori, Alecensa significantly reduced the risk of progression or death (no progression survival (PFS)) by 53% (HR-0.47,95% CI: 0.34-0.65, p.0.0) 001), at the same time to make tumor brain metastasis or central nervous system (CNS) metastasis or brain/CNS brain tumor growth risk significantly reduced by 84% (HR: 0.16, 95% CI: 0.10-0.28, p 0.0001) studies, although Alecensa was treated for a longer duration (17.9 months vs 10.7 months), it showed more favorable safety and tolerance