Ensacove (ensartinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::ALK	Non-Small Cell Lung Cancer	Ensartinib