Posted by Michael Wonder on 13 Oct 2017
CHMP recommends EU approval of Roche’s Alecensa (alectinib) as a first-line treatment for people with ALK-positive NSCLC
13 October 2017 - Positive opinion based on phase III results showing Alecensa reduced the risk of disease progression or death by more than half versus crizotinib.
Roche announced today that the European Union’s CHMP has adopted a positive opinion recommending the approval of Alecensa (alectinib) as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase positive, advanced non-small cell lung cancer.
It has also simultaneously recommended the conversion of the current conditional marketing authorisation for Alecensa in crizotinib failure (second-line) to a full marketing authorisation.
