Genentech announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review for alectinib 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.
The NDA for alectinib includes data from two Phase 2 studies. NP28761 (North America) and NP28673 (global) are both single-arm, open-label, multicenter trials evaluating the safety and efficacy of alectinib in people with ALK-positive NSCLC whose disease progressed on crizotinib. ALEX, an ongoing, global randomized Phase 3 study is comparing alectinib to crizotinib as a first-line treatment for people with advanced ALK-positive NSCLC.
In June 2013, alectinib was granted Breakthrough Therapy designation by the FDA for the same indication. The FDA will make a decision on approval by March 4, 2016.
Alectinib is an oral investigational anaplastic lymphoma kinase (ALK) inhibitor for certain people with NSCLC whose tumors are identified as ALK-positive.
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