Genentech, a member of the global pharmaceutical giant Roche Group, announced that that the U.S. FDA has awarded Priority Review to its alectinib for the treatment of ALK (anaplastic lymphoma kinase)-positive lung cancer after accepting the company’s New Drug Application.    Lung cancer is the leading cause of cancer deaths in the United States.  Non-small cell lung cancer (NSCLC) accounts for 85% of lung cancer and about 5% of people with NSCLC are ALK-positive.    Alectinib is an orally available inhibitor of ALK and it received a Breakthrough Therapy Designation from the FDA in June 2013 for people with ALK-positive, locally advanced or metastatic NSCLC who have progressed on or are intolerant to crizotinib.  This Priority Review status is based on promising results from two Phase II trials in people with ALK-positive NSCLC that progressed on crizotinib.  Currently, the company is conducting a Phase III study with the goal of comparing alectinib to crizotinib as a first-line treatment for people with ALK-positive advanced NSCLC.

 

Original Article:

http://www.gene.com/media/press-releases/14605/2015-09-08/fda-grants-genentechs-alectinib-priority