Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized alectinib as a monotherapy for the adjuvant treatment following complete tumor 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 as:

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.

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.

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