Vitrakvi Indications/Uses

VITRAKVI (larotrectinib) is indicated for the treatment of adult and pediatric patients with solid tumours that: have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have no satisfactory treatment options.
This indication is approved based on overall response rate (ORR) and duration of response (DOR) in a pooled patient population in which most patients had rare tumours (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions).
Treatment with VITRAKVI should be initiated following confirmation of an NTRK gene fusion in a tumour specimen using a validated test (see Pharmacology: Mechanism of Action under Actions).
VITRAKVI should only be administered under the supervision of a health professional experienced in the use of antineoplastic agents.
Pediatrics: Pediatrics (< 18 years of age): The safety and efficacy of VITRAKVI in pediatric patients 28 days and older were established based upon data from three multicenter, open-label, single-arm clinical studies. There are no data in pediatric patients less than one month of age (see Use in Children under Precautions).
Geriatrics: Geriatrics (≥ 65 years of age): The safety and efficacy of VITRAKVI in geriatric patients were established based upon data from three multicenter, open-label, single-arm clinical studies. Insufficient numbers of patients aged 65 and over were included to determine whether they respond differently from younger subjects (see Use in the Elderly under Precautions).