FDA approves ensartinib for ALK-positive locally advanced or metastatic NSCLC
The approval covers adult patients who have not previously received an ALK-inhibitor.
The Food and Drug Administration approved ensartinib, marketed as Ensacove by Xcovery Holdings, Inc., on December 18, 2024, for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor.1
The approval is limited to this specific patient population: those with locally advanced or metastatic disease who are ALK-inhibitor naive.
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