Genentech, a member of the Roche Group (RHHBY), announced that the U.S. Food and Drug Administration or FDA has accepted the company’s New Drug Application or NDA and granted Priority Review for alectinib, an oral investigational anaplastic lymphoma kinase or ALK inhibitor, for the treatment of people with ALK-positive, locally advanced or metastatic non-small cell lung cancer or 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.
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.
ALEX, an ongoing, global randomized Phase III study is comparing alectinib to crizotinib as an initial (first-line) treatment for people with advanced NSCLC whose tumors were characterized as ALK-positive by a companion immunohistochemistry (IHC) test developed by Roche Diagnostics.
Alectinib is an oral medicine created at Chugai Kamakura Research Laboratories for certain people with NSCLC whose tumors are identified as ALK-positive. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history.
by RTT Staff Writer