entrectinib (Rozlytrek)

following a full submission considered under the end of life and orphan equivalent process:

entrectinib (Rozlytrek ®) is accepted for use within NHSScotland.

Indication under review: 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

In a pooled analysis of three phase I/II studies in adults with metastatic or locally advanced NTRK fusion-positive solid tumours, 64% of patients achieved an objective response with entrectinib treatment. The median duration of response in these patients was 12.9 months. Positive objective response rate results were also reported in a phase I/Ib paediatric study.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.