FDA approves ensartinib for ALK-positive locally advanced or metastatic NSCLC
“On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor. The main efficacy outcome measure was progression-free survival (PFS) as evaluated by blinded independent central review. The key secondary efficacy outcome measure was overall survival (OS). Ensartinib demonstrated a statistically significant PFS improvement compared to crizotinib with a hazard ratio (HR) of 0.56 (95% CI: 0.40, 0.79; p-value 0.0007). The median PFS was 25.8 months (95% CI: 21.8, not estimable) in the ensartinib arm and 12.7 months (95% CI: 9.2, 16.6) in the crizotinib arm. There was no statistically significant difference in OS (HR 0.88 [95% CI: 0.63, 1.23], p-value 0.4570).”
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