FDA Approves Ensartinib for Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer
On December 18, 2024, the US Food and Drug Administration (FDA) approved ensartinib for patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received ALK inhibitors. This approval was based on results from the eXALT3 trial.
In this open-label, active-controlled study, 290 patients were randomized on a 1-to-1 basis to receive either ensartinib or crizotinib, until disease progression or unacceptable toxicity. The primary end point was progression-free survival (PFS). Key secondary end points included overall survival (OS), and safety.
At analysis, the median PFS was 25.8 months in the ensartinib arm and 12.7 months in the crizotinib arm (hazard ratio [HR], 0.56; 95% confidence interval [CI], 0.40 to 0.79; P = .0007). There was no statistically significant difference in OS (HR, 0.88; 95% CI, 0.63 to 1.23; P = .4570). The most common adverse events occurring in ≥ 20% of patients included rash, musculoskeletal pain, constipation, cough, pruitis, nausea, edema, pyrexia, and fatigue.
The recommended dose of ensartinib is 225 mg once daily with or without food until disease progression or unacceptable toxicity.
Source:
FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer. Accessed on December 18, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ensartinib-alk-positive-locally-advanced-or-metastatic-non-small-cell-lung-cancer
