General Information

Alecensa (alectinib) is a kinase inhibitor that targets ALK and RET.

Alecensa is specifically indicated 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.

Alecensa is supplied as a capsule for oral administration. The recommended dose is 600 mg orally twice daily, taken with food. Administer until disease progression or unacceptable toxicity. Please see drug label for specific dose modifications.

Clinical Results

FDA Approval

Alecensa was granted accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Accelerated approval was based on the results of two single-arm clinical trials of patients with metastatic ALK-positive NSCLC whose disease was no longer controlled by treatment with Xalkori. Subjects received Alecensa twice daily to measure the drug’s effect on their lung cancer tumors. In the first study, 38 percent of subjects experienced a partial shrinkage of their NSCLC tumors, an effect that lasted for an average of 7.5 months. In the second study, 44 percent of subjects experienced a partial shrinkage of their NSCLC tumors, lasting for an average of 11.2 months. The trials also examined Alecensa’s effect on brain metastases, a common occurrence in this population. Sixty-one percent of subjects in the two trials who had measurable brain metastases experienced a complete or partial reduction in their brain tumors, lasting an average of 9.1 months.

Mechanism of Action

Alecensa (alectinib) is a kinase inhibitor that targets ALK and RET. In nonclinical studies, alectinib inhibited ALK phosphorylation and ALK-mediated activation of the downstream signaling proteins STAT3 and AKT, and decreased tumor cell viability in multiple cell lines harboring ALK fusions, amplifications, or activating mutations. The major active metabolite of alectinib, M4, showed similar in vitro potency and activity.