Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to alectinib for the adjuvant treatment of adult patients, following tumor resection, with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors >= 4 cm or node positive), as detected by an FDA-approved test.

This is written in the approval document as:

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.

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) v::ALK Non-Small Cell Lung Cancer Alectinib