Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved entrectinib for reimbursement as a monotherapy treatment option for the treatment of adult patients with solid tumors expressing 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 not received a prior NTRK inhibitor, and (iii) who have no satisfactory treatment options.

This is written in the approval document as:

For the treatment of adult patients with solid tumors expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who: (i) have a disease that is locally advanced, metastatic, or where surgical resection is likely to result in severe morbidity, and (ii) who have not received a prior NTRK inhibitor, and (iii) who have no satisfactory treatment options.

Reimbursement

CDS

Citation

Entrectinib Monotherapy - Adult, 2024, version number 2, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6770/702_V2_Entrectinib_monotherapy.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	Entrectinib
HSE (1)	v::NTRK2	Any solid tumor	Entrectinib
HSE (1)	v::NTRK3	Any solid tumor	Entrectinib

Contributions

Date	Contributor	Description
2024-10-01	Health Service Executive	Indication approved for reimbursement.
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database