2 Information about entrectinib

Marketing authorisation indication

2.1 Entrectinib (Rozlytrek, Roche) is indicated as monotherapy for the 'treatment of adult and paediatric patients 12 years of age and older, with solid tumours expressing 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 not received a prior NTRK inhibitor

  • who have no satisfactory treatment options'.

Dosage in the marketing authorisation

2.2 The dosage schedule is available in the summary of product characteristics.


2.3 The list price for entrectinib is £5,160.00 per 90‑tablet pack of 200 mg tablets (excluding VAT, company submission). The company has a commercial arrangement. This makes entrectinib available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)