FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Genentech’s Alectinib Wins Frontline Approval

Nov. 10, 2017

The FDA cleared Genentech’s alectinib for frontline treatment of ALK-positive metastatic non-small cell lung cancer.

The agency based its approval on a phase III study that found the drug improved progression-free survival by 47 percent compared to crizotinib. The FDA further expanded its accelerated approval for ALK-positive NSCLC patients who have progressed on crizotinib, making it a full approval.

The trial comprised 161 locations in 31 countries. The approval comes after the FDA designated alectinib a breakthrough therapy.

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