Xcovery Holdings, Inc.

FDA approved ensartinib for ALK-positive NSCLC after phase 3 eXALT3 trial results. Ensartinib showed longer median PFS (25.8 months) vs crizotinib (12.7 months). Common AEs included rash, musculoskeletal pain, and constipation. No new safety signals observed.

Xcovery Holdings, Inc. announced FDA approval of ensartinib for ALK-positive locally advanced or metastatic NSCLC, based on Phase III eXalt3 trial data showing improved PFS over crizotinib. Ensartinib is a next-gen ALK inhibitor developed by Xcovery and Betta Pharmaceuticals.

FDA approved ensartinib (Ensacove) for ALK-positive locally advanced or metastatic NSCLC on Dec 18, 2024. Ensartinib showed significant PFS improvement over crizotinib in a trial, with a median PFS of 25.8 months vs 12.7 months. Common adverse reactions include rash, musculoskeletal pain, constipation, and cough. Recommended dose is 225 mg orally once daily.