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The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1 Larotrectinib is not recommended, within its marketing authorisation, for treating advanced neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours in adults and children who have no satisfactory treatment options.

1.2 This recommendation is not intended to affect treatment with larotrectinib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. For children and young people, this decision should be made jointly by the clinician and the child or young person or their parents or carers.

Why the committee made these recommendations

There is no standard treatment for NTRK fusion-positive solid tumours, so current treatment is based on where in the body the cancer starts. Larotrectinib is a histology-independent treatment. This means that it targets a genetic alteration, NTRK gene fusion, that is found in many different tumour types irrespective of where the cancer starts.

Evidence from trials suggests that tumours with NTRK gene fusions shrink in response to larotrectinib. But it is difficult to know how well larotrectinib works because it has not been compared in the trials with other treatments. There is little or no evidence about whether larotrectinib works well for every type of NTRK fusion-positive tumour.

The cost-effectiveness estimates for larotrectinib are very uncertain because of limitations in the data, such as the substantial uncertainty about how long people would live after their disease gets worse. Further data collection would help to address the uncertainties in the clinical evidence. However, larotrectinib does not have the potential to be a cost-effective use of NHS resources at its current price so it is not recommended for routine commissioning, or through the Cancer Drugs Fund.