Posted by Michael Wonder on 17 Dec 2016
CHMP recommends EU conditional approval of Roche’s Alecensa (alectinib) for people with previously treated ALK-positive NSCLC
16 December 2016 - Roche announced today that the EMA CHMP has adopted a positive opinion for the use of Alecensa (alectinib) for the treatment of adult patients with advanced anaplastic lymphoma kinase positive non-small cell lung cancer whose disease has progressed following treatment with crizotinib.
ALK-positive NSCLC occurs in approximately five percent of people with advanced NSCLC, translating to about 75,000 people globally being diagnosed with the disease per year. ALK-positive disease is more common in light or non-smokers.
Based on this positive CHMP recommendation, a final decision regarding the conditional marketing authorisation is expected from the European Commission in the coming months.
