FDA Approves New Drug Application for Alectinib


The US Food and Drug Administration (FDA) has approved the supplemental New Drug Application for alectinib as a first-line treatment for patients with a specific type of lung cancer.

Alectinib (Alecensa, Genentech) received Breakthrough Therapy Designation for the FDA in 2016 for the treatment of adults with advanced ALK-positive non-small cell lung cancer (NSCLC)  who have not received prior treatment with an ALK inhibitor. Today, the FDA approved alectinib for the treatment of patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.

The approval is based on results for a recent phase III trial (ALEX), which demonstrated the drug’s ability to reduce the risk of disease worsening or death by 47% compared to crizotinib. The median progression-free survival was 25.7 months for patients taking alectinib, compared with 10.4 months for those taking crizotinib. Alectinib also reduced the risk of cancer spreading to or growing in the brain or central nervous system by 84% compared to crizotinib.

The safety profile of alectinib was consistent with that observed in previous studies.


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“Our goal is to develop medicines that have the potential to significantly improve upon the standard of care,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “In our pivotal study, Alecensa significantly extended the time that people lived without their disease worsening compared to crizotinib and also showed a marked reduction in the risk of their cancer spreading to the brain.”—Zachary Bessette