Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved larotrectinib monotherapy for reimbursement for the treatment of pediatric 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 paediatric 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
Citation
Larotrectinib Monotherapy - Paediatric, 2023, version number 2, NCCP National SACT Regimen, NCCP, viewed 01/02/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/tumour%20agnostic%20therapy/760%20larotrectinib-monotherapy-paediatric.pdfTherapeutic 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 | Larotrectinib | |
| Sensitivity (+) | v::NTRK2 | Any solid tumor | Larotrectinib | |
| Sensitivity (+) | v::NTRK3 | Any solid tumor | Larotrectinib |