Larotrectinib

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 14 CLINICAL TRIALS). 1 Mechanism of Action). VITRAKVI should only be administered under the supervision of a health professional experienced in the use of antineoplastic agents.

1 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. 3 Pediatrics).

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1 INDICATIONS AND USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine 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 alternative treatments or that have progressed following treatment.

1) ]. VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine 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 alternative treatments or that have progressed following treatment.

Select patients for therapy based on an FDA-approved test. 1 )

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