NEWS

Roche Targeted Cancer Drug Alecensa Approved by NMPA

Release time:

2018-10-18 15:35

Swiss pharmaceutical giant Roche (Roche) recently announced that China's State Drug Administration (NMPA) ApprovedAlecensa(alectinib, alemetinib) as a monotherapy for anaplastic lymphoma kinase (ALK) Positive advanced NSCLC (NSCLC) treatment of patients. It is worth mentioning that,AlecensaApproved through priority review, the approval time is only longer than that of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) First-line approval is late8months and9Months.

This approval is based on criticalIIIphase clinical studyALEXThe main analysis data, carried out in Asian patients.IIIphase clinical studyALESIAPharmacokinetic data on targeted anticancer drugsXalkori(Crizotinib, crizotinib) in patients who are intolerant or have progressed after receiving the drug2ItemIIData from clinical studies.

The results show that,Xalkoricompared,Alecensarisk of progression or death (progression-free survival[PFS]) significantly reduced53%(HR=0.47,95% CI:0.34-0.65,p<0.0001), at the same time make the tumor brain metastasis or central nervous system (CNS) metastasis or brain/CNSSignificantly reduced risk of brain tumor growth84%(HR=0.16,95%CI:0.10-0.28,p<0.0001); in the study, althoughAlecensaLong duration of treatment (17.9Monthsvs 10.7months), but showed a more favorable safety and tolerability.

AlecensaPatents have been applied in many countries, including China, the United States, Argentina, Canada, Japan, South Korea, etc. Among them, the Chinese patent protects the compounds shown in the figure below.

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