Alecensa Approved as First-Line Tx in ALK-Positive Metastatic NSCLC

The safety profile of Alecensa was consistent with that seen in previous studies
The safety profile of Alecensa was consistent with that seen in previous studies

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.

For more information visit Gene.com.