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FDA Approves Adjuvant Alectinib for Patients With Resected ALK-Positive Non-Small Cell Lung Cancer
On April 18, 2024, the US Food and Drug Administration (FDA) approved alectinib in the adjuvant setting for patients with resected ALK-positive non-small cell lung cancer (NSCLC), as detected by an FDA approved test. This approval was based on results from the global phase 3 ALINA trial.
In this open-label trial, 257 patients with stage IB, II, or IIIA ALK-positive NSCLC who underwent surgical resection were enrolled. Patients were randomized on a 1-to-1 basis to receive either 600 mg of alectinib twice daily or platinum-based chemotherapy. The major efficacy outcome measure was median investigator-assessed disease-free survival (DFS) in both the intention-to-treat population and in a subgroup of patients with stage II or IIIA disease.
In the intention-to-treat population, median DFS was not reached in the alectinib arm and was 41.3 months in the chemotherapy arm (hazard ratio [HR] 0.24; 95% confidence interval [CI], 0.13 to 0.43; P < .0001). In the subgroup of patients with stage II or IIIA disease, median DFS was not reached in the alectinib arm and was 44.4 months in the chemotherapy arm (HR 0.24; 95% CI, 0.13 to 0.45; P < .0001). The most common adverse reactions occurring in ≥20% of patients included hepatotoxicity, constipation, myalgia, COVID-19, fatigue, rash, and cough.
The recommended dose of alectinib is 600 mg twice daily with food for 2 years or until disease recurrence or unacceptable toxicity.
Source:
FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer. Published online: April 18, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-alectinib-adjuvant-treatment-alk-positive-non-small-cell-lung-cancer
