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The FDA has granted Breakthrough Therapy Designation for the anaplastic lymphoma kinase (ALK) inhibitor alectinib (Alecensa) for the treatment of adult patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor.

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The FDA's Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious diseases and help ensure patients have access to them through FDA approval as soon as possible. Alectinib received its first designation in June 2013 for people with ALK-positive NSCLC whose disease progressed on treatment with crizotinib.


Alectinib was granted accelerated approval by the FDA in December 2015 for the treatment of people with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib. ALEX, a global, randomized phase III study, is ongoing, comparing alectinib to crizotinib as a first-line treatment for people with advanced NSCLC whose tumors were characterized as ALK-positive by a companion VENTANA ALK (D5F3) CDx Assay immunohistochemistry test.