Larotrectinib
Larotrectinib (Vitrakvi, Bayer AG) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: NTRK (1).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Solid tumours, tumour-agnostic1 | |||
NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
Full text of section 4.1 (therapeutic indications)
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).
Label history
19 changes to the Vitrakvi label since 2020, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes