Alecensa (alectinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
ALECENSA is a kinase inhibitor indicated for the adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors >= 4 cm or node positive) as detected by an FDA-approved test.	1
ALECENSA is a kinase inhibitor indicated for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	v::ALK	Non-Small Cell Lung Cancer	Alectinib