The Food and Drug Administration (FDA) has approved Alecensa (alectinib) capsules for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic, non-small cell lung cancer (NSCLC), who have progressed on or are intolerant to crizotinib. The announcement was made by Genentech.

The indication for Alecensa is approved under the FDA’s Accelerated Approval Program based on tumor response rate and duration of response (DOR). 

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Alecensa, a kinase inhibitor, was examined in Study 1 (n=87), a Phase 2 North American, single-arm, open-label, multicenter trial. It was also examined in Study 2 (n=138), a Phase 1/2 global, single-arm, open-label, multicenter trial. The primary endpoint for both trials was overall response rate (ORR) according to RECIST v1.1 Results were evaluated by an independent review committee.

Alecensa shrank tumors in up to 44% of patients with ALK-positive NSCLC who progressed on crizotinib (ORR 38%, 95% CI: 28-49; ORR 44%, 95% CI: 36-53). For patients with tumors that metastasized to the brain or other parts of the central nervous system (CNS), Alecensa shrank CNS tumors in about 60% of patients (ORR 61%, 95% CI: 46-74). 

Alecensa is also being investigated for use as first-line treatment for patients with advanced ALK-positive NSCLC. A global, randomized Phase 3 study (ALEX) is comparing Alecensa to crizotinib as initial treatment in patients with advanced NSCLC whose tumors are characterized as ALK-positive. 

Alecensa will be available as 150mg strength capsules in 240-count bottles. It is anticipated to launch within 2 weeks. 

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