Regulatory approval

Published by the European Medicines Agency. Approved

Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK-positive non-small cell lung cancer (NSCLC) at high risk of recurrence.

This is written in the approval document.

Citation

Roche Registration GmbH. Alecensa (alectinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_en.pdf. Revised June 2024. Accessed October 18, 2024.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	v::ALK	Non-Small Cell Lung Cancer	Alectinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2024-06-06	European Medicines Agency	Indication received approval from the European Commission.