Alecensa (alectinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

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

Indication	Statements
Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).	1
Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.	1
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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