FDA Approves Ensartinib for First-Line Treatment of ALK-Positive NSCLC

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)14.

Clinical Trial:
The approval is based on data from the pivotal global Phase III eXalt3 clinical trial, which demonstrated statistically significant improvements in progression-free survival (PFS) over crizotinib1.

Drug Mechanism:
Ensartinib is an ALK tyrosine kinase inhibitor (TKI) designed to disrupt ALK-mediated signaling, thereby blocking the hyperactive growth and proliferation typical of cancer cells2.

Company Background:
Xcovery Holdings, Inc. is an oncology-focused pharmaceutical company working to improve the lives of patients with cancer by discovering and developing small molecules that precisely target cancer growth mechanisms1.

Approval Date:
The FDA approval was granted on December 18, 20245.

Sources:

1. https://www.biospace.com/press-releases/fda-approval-of-ensartinib-for-alk-positive-locally-advanced-or-metastatic-non-small-cell-lung-cancer-nsclc

2. https://www.biospace.com/biospace-fda-decision-tracker

4. https://endpts.com/xcovery-nabs-first-fda-approval-for-lung-cancer-drug/

5. https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications