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Priority Review Granted for Alectinib for Initial Treatment of ALK-Positive Lung Cancer

Posted: Friday, August 4, 2017

Yesterday, Genentech announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application and granted Priority Review for alectinib (Alecensa) as an initial treatment of anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non–small cell lung cancer (NSCLC) as detected by an FDA-approved test. The FDA is expected to make a decision on approval by November 30, 2017.

This supplemental New Drug Application submission is based on results from the phase III ALEX and J-ALEX studies. In the ALEX trial, alectinib was found to reduce the risk of disease worsening or death by 53% compared with crizotinib (hazard ratio [HR] = 0.47, 95% confidence interval [CI]: 0.34–0.65, P<.0001). Investigator-reported median progression-free survival (the primary endpoint) was not yet reached in the alectinib arm versus 11.1 months in the crizotinib arm. Independent review committee–reported median progression-free survival (a secondary endpoint) was 25.7 months with alectinib compared with 10.4 months with crizotinib.

In addition, alectinib reduced the risk of disease progression in the central nervous system (CNS) by 84 % versus crizotinib. The 12-month cumulative rate of CNS progression for patients with or without existing CNS metastases at baseline was 9.4% with alectinib and 41.4% with crizotinib.

Overall survival data are currently considered immature, with only about one-quarter of events being reported.

Similar benefits with alectinib over cabozantinib were reported in the J-ALEX study as well.