Regulatory approval

Published by the Food and Drug Administration. Approved

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

This is written in the approval document.

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.

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

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.