Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved alectinib for reimbursement as a monotherapy treatment option for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). This indication is specifically for patients whose tumors have been historically confirmed to be NSCLC with an ALK rearrangement identified by an approved and validated test method.

This is written in the approval document as:

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).

Reimbursement

CDS

Citation

Alectinib Monotherapy, 2025, version number 6, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6910/401_V6_Alectinib.pdf

Therapeutic response

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

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

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2019-06-01	Health Service Executive	Indication approved for reimbursement.