9 September 2015 - Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for alectinib, an oral investigational anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of people with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Alectinib was granted Breakthrough Therapy Designation by the FDA in June 2013 for people with ALK-positive NSCLC whose disease progressed on crizotinib.

“Alectinib was granted Priority Review by the FDA based on results from two studies showing the medicine shrank tumors in people with ALK-positive NSCLC that progressed on crizotinib,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “There is a need for new treatment options in this patient population, especially because the disease often spreads to the brain at progression.”

A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. The NDA for alectinib includes data from two Phase II studies (NP28761 and NP28673), and the FDA will make a decision on approval by March 4, 2016.

For more details, go to: http://www.businesswire.com/news/home/20150908006869/en/FDA-Grants-Genentech’s-Alectinib-Priority-Review-Specific#.VfAgsLTC1Vs