The FDA approved a new indication for alectinib (Alecensa, Genentech) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
The approval is based on results from the ALEX study, an open-label, randomized, active-controlled, multicenter, phase 3 study evaluating the efficacy and safety of alectinib versus crizotinib (Xalkori, Pfizer) in people with ALK-positive NSCLC who had not received