ALK TKI Earns FDA Approval
The ALK tyrosine kinase inhibitor (TKI) ensartinib (Ensacove; Xcovery) was approved for patients with locally advanced or metastatic ALK-positive non–small cell lung cancer (NSCLC). The decision was based on results from the phase III eXALT3 trial, in which patients with NSCLC who had not already received an ALK TKI took either ensartinib or crizotinib (Xalkori; Pfizer). Median progression-free survival, the study’s primary outcome, was 25.8 months in the ensartinib group and 12.7 months in the crizotinib group. There was no statistically significant difference in overall survival between the two treatment groups.
