NICE recommends ‘game changing’ histology independent cancer drug

Larotrectinib (also called Vitrakvi and made by Bayer), is a new treatment for a range of cancers, has been recommended for use in the Cancer Drugs Fund (CDF).

A new treatment for many cancer types, has been recommended for use on the Cancer Drugs Fund (CDF).

Larotrectinib is a histology independent cancer treatment that targets all solid tumours with a certain genetic mutation (the NTRK gene fusion) regardless of where the primary tumour is in the body.

This positive recommendation is a change to the initial decision where the price of larotrectinib was too high to be considered cost-effective. There was also uncertainty in the clinical evidence as larotrectinib has not been compared with other treatments.

The company has since submitted a new price which now means patients can access larotrectinib through the CDF while further data can be collected to address some of the clinical uncertainties.

Histology independent cancer drugs target all solid tumours with a certain genomic mutation, regardless of where the primary tumour is in the body. They are one of the three priority categories of early-stage focus for the Accelerated Access Collaborative, a cross-sector partnership aimed at accelerating access to transformative health technologies, of which NICE is one of the partners.

Meindert Boysen, director of the centre for health technology evaluation at NICE, said: “Histology independent medicines, like larotrectinib, are an exciting new development in the treatment of cancer. These cutting-edge therapies can be used to treat tumours with often rare genetic mutations regardless of where in the body the tumour originated.

The clinical evidence is usually based on extremely small sample sizes, requiring novel approaches to testing them in clinical trials and translation into models of assessment for potential value in NHS practice.

“We’re therefore pleased to be able to recommend larotrectinib for use in the Cancer Drugs Fund while more data is collected on its clinical effectiveness, and we recognise the contribution of our appraisal committee, the company and other stakeholders.”

This cutting-edge therapy is set to benefit adults and children with advanced neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours, who have no satisfactory treatment options.

Between 600–700 people have solid tumours with NTRK gene fusions. A proportion of these people, who have no satisfactory treatment options, will be eligible for treatment within the first year that it’s available on the CDF.

Histology independent medicines, like larotrectinib, are an exciting new development in the treatment of cancer.

Meindert Boysen, director of the centre for health technology evaluation at NICE.