The Food and Drug Administration (FDA) has approved Alecensa (alectinib; Genentech) as a first-line treatment for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. 

The approval was based on the Phase 3 ALEX study which evaluated the safety and efficacy of Alecensa versus crizotinib in patients with ALK-positive NSCLC who had not received prior systemic therapy for metastatic disease and whose tumors were characterized as ALK-positive by the VENTANA ALK CDx Assay. 

Compared to crizotinib, Alecensa significantly reduced the risk of disease worsening or death by 47% (HR=0.53, 95% CI: 0.38–0.73, P<0.0001) as assessed by independent review committee. Median progression-free survival was 25.7 months (95% CI: 19.9, not estimable) for the Alecensa arm compared with 10.4 months (95% CI: 7.7–14.6) for those who received crizotinib. 

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Alecensa also significantly reduced the risk of cancer spreading to or growing in the brain or central nervous system compared to crizotinib by 84% (HR=0.16, 95% CI: 0.10–0.28, P<0.0001).

In addition, the FDA granted full approval to Alecensa for the treatment of patients with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib.

Alecensa, a kinase inhibitor, is available in 150mg capsules.

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