Alectinib NDA Accepted With Priority Review for NSCLC

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.

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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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