Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

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	Ceritinib

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.