Therapeutic Response Statement (Sensitivity)

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

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

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.

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. Takeda Pharmaceuticals America, Inc. Alunbrig (brigatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208772s008lbl.pdf. Revised May 2020. Accessed October 6, 2026.

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.