Regulatory approval

Published by the Food and Drug Administration. Approved

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

This is written in the approval document.

Citation

Takeda Pharmaceuticals America, Inc. Alunbrig (brigatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208772s013lbl.pdf. Revised February 2022. 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	Brigatinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2020-05-22	Food and Drug Administration	Indication received traditional approval.