CHMP recommends Roche's Alecensa for first-line NSCLC

EMA's CHMP recommended approval of Alecensa alectinib (AF802, CH5424802, RG7853, RO5424802) from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) as monotherapy for first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC).

The committee also recommended full approval of Alecensa as a second-line therapy for ALK-positive NSCLC in patients who failed treatment with Xalkori crizotinib. Alecensa has accelerated approval in the U.S. and conditional approval in the EU for the second-line indication...