Regulatory approval
Published by the Health Service Executive.
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).
Citation
Alectinib Monotherapy, 2021, version number 5, NCCP National SACT Regimen, NCCP, viewed 16/12/2023, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/lung/401.pdfTherapeutic 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 |