Regulatory approval
Published by the Health Service Executive. Approved
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
This is written in the approval document.
Reimbursement
CDS
Subject to a managed access protocol
Citation
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 |