Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that v::ALK status confers therapeutic sensitivity to Ensartinib in patients with Non-Small Cell Lung Cancer.

The U.S. Food and Drug Administration (FDA) granted approval to ensartinib 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 statement is based on a regulatory approval from the Food and Drug Administration:

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.

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. 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 October 6, 2026.

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.