Regulatory approval

Published by the Health Service Executive.

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.

Citation

Entrectinib Monotherapy - Adult, 2024, version number 2, NCCP National SACT Regimen, NCCP, viewed 16/10/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/lung/702-entrectinib-therapy.pdf

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::NTRK1	Any solid tumor	Entrectinib
Sensitivity (+)	v::NTRK2	Any solid tumor	Entrectinib
Sensitivity (+)	v::NTRK3	Any solid tumor	Entrectinib