Therapeutic Response Statement (Sensitivity)

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

The U.S. Food and Drug Administration granted approval to ceritinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

This statement is based on a regulatory approval from the Food and Drug Administration:

ZYKADIA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

Citation

Novartis Pharmaceuticals Corporation. Zykadia (ceritinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211225s004lbl.pdf. Revised October 2021. Accessed October 30, 2024. Novartis Pharmaceuticals Corporation. Zykadia (ceritinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211225s000lbl.pdf. Revised March 2019. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2019-03-18	Food and Drug Administration	Indication received traditional approval.