Therapeutic Response Statement (Sensitivity)

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

The U.S. Food and Drug Administration granted approval to alectinib 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:

ALECENSA is a kinase inhibitor indicated for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.

Citation

Genentech, Inc. Alecensa (alectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208434s015lbl.pdf. Revised February 2023. Accessed October 30, 2024. Genentech, Inc. Alecensa (alectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208434s003lbl.pdf. Revised November 2017. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2017-11-06	Food and Drug Administration	Indication received traditional approval.
2015-12-11	Food and Drug Administration	Indication received accelerated approval.