NTRK
3 EU-approved indications of 3 drugs need a NTRK result, in 1 tumour type, most of them in solid tumours, tumour-agnostic.
Approved indications3
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| Solid tumours, tumour-agnostic3 | ||||
Rozlytrekconditional | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options | |
Vitrakviconditional | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options | |
Augtyroconditional | Monotherapy | Any line advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older | |
Label wording3
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Entrectinib (Rozlytrek)
Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients older than 1 month with solid tumours that have a NTRK gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor who have no satisfactory treatment options (see sections 4.4 and 5.1).
- Larotrectinib (Vitrakvi)
VITRAKVI as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, - who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and - who have no satisfactory treatment options (see sections 4.4 and 5.1).
- Repotrectinib (Augtyro)
AUGTYRO as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)