FDA Approves Ensacove for ALK-Positive Locally Advanced or Metastatic NSCLC

The FDA approved ensartinib (Ensacove, Xcovery Holdings) 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.

Efficacy was evaluated in eXalt3 (ClinicalTrials.gov. Identifier: NCT02767804), an open-label, randomized, active-controlled, multicenter trial in 290 patients with locally advanced or metastatic ALK-positive NSCLC who had not previously received an