Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved larotrectinib monotherapy for reimbursement for the treatment of adult patients with solid tumors that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. This indication is for patients whose disease is locally advanced, metastatic, or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.

This is written in the approval document as:

For the treatment of adult patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, (i) who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and (ii) who have no satisfactory treatment options

Reimbursement

CDS

Citation

Larotrectinib Monotherapy - Adult, 2024, version number 3, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6788/758_V3_Larotrectinib_Therapy_Adult.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	v::NTRK1	Any solid tumor	Larotrectinib
HSE (1)	v::NTRK2	Any solid tumor	Larotrectinib
HSE (1)	v::NTRK3	Any solid tumor	Larotrectinib

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2023-05-01	Health Service Executive	Indication approved for reimbursement.