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Larotrectinib for treating NTRK fusion-positive solid tumours

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2 Information about larotrectinib

Marketing authorisation indication

2.1 Larotrectinib (Vitrakvi, Bayer) has a conditional marketing authorisation 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'.

Dosage in the marketing authorisation

2.2 Adults: The recommended dose in adults is 100 mg larotrectinib twice daily, until disease progression or until unacceptable toxicity occurs. Children: Dosing in children is based on body surface area. The recommended dose is 100 mg/m2 larotrectinib twice daily with a maximum of 100 mg per dose until disease progression or until unacceptable toxicity occurs.

Price

2.3 The cost of larotrectinib is £5,000 per 100-ml vial of 20 mg/ml oral solution (excluding VAT; BNF online, accessed January 2020; £15,000 per 30-day supply). Larotrectinib will be available as hard capsules (25 mg and 100 mg) to be taken orally twice daily (company submission). The company has a commercial arrangement which would have applied if the technology had been recommended.