Regulatory approval

Published by the Food and Drug Administration. Approved

ENSACOVE is a kinase inhibitor indicated for the treatment of 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.

This is written in the approval document.

Citation

Xcovery Holdings, Inc. Ensacove (ensartinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218171s000lbl.pdf. Revised December 2024. Accessed January 10, 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	v::ALK	Non-Small Cell Lung Cancer	Ensartinib

Contributions

Date	Contributor	Description
2025-01-10	Van Allen lab	Additional FDA approvals for initial version
2024-12-18	Food and Drug Administration	Indication received traditional approval.