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Another histology independent treatment, entrectinib (made by Roche), which NICE is also appraising could become the first histology independent treatment to be available to patients, provided it receives its marketing authorisation. NICE will be able to say more on this following a preliminary decision on its European licence.

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.

Both drugs offer a new option to patients, including for some rare types of cancer, where treatments are currently limited.

The draft guidance considers larotrectinib for treating advanced neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours, in adults and children who have no satisfactory treatment options.

Meindert Boysen, director of the centre for health technology evaluation at NICE, said: “Histology independent medicines are an exciting new development in cancer care. These cutting-edge therapies target rare genetic mutations, so the clinical evidence is usually based on extremely small sample sizes, requiring novel approaches to testing them in clinical trials. Therefore, further data collection is likely to be needed, for example through the Cancer Drugs Fund (CDF).

“Larotrectinib and entrectinib offer a major change in the treatment of NTRK fusion-positive solid tumours. The introduction of a new NHS Genomic Medicine Service is expected to support the uptake of these progressive therapies, testing tens of thousands of solid tumours solid tumours per year once it is fully established. These advances represent important steps in the NHS long-term plan, enabling eligible patients to be identified, and treated, quicker.

“We’re hopeful that further data collection, coupled with responsible pricing from the companies, will lead to progressive, new treatments like these being available to patients. As a partner in the Accelerated Access Collaborative, NICE will do all it can to assist the company in providing the reassurances required to allow larotrectinib to be recommended for inclusion in the CDF.”

NTRK gene fusions are thought to drive tumour growth. Solid tumours with NTRK gene fusions occur in less than 1% of common tumours such as lung, colorectal and breast cancers. The mutation is much more common in certain rare cancers.

Around 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 one of these therapies within the first year that they’re available on the NHS.

There is no standard treatment for NTRK fusion-positive tumours, so current treatment is based on where in the body the cancer starts.

John Stewart, NHS national director of specialised commissioning, said: “It is disappointing that Bayer has not yet been willing to price larotrectinib at a level which represents value for the NHS and the taxpayer, however, should they reconsider, the NHS’ door remains open for further discussion.

“In the meantime, preparation continues for the introduction of this next generation of therapies, including constructive conversations with Roche on a commercial deal for entrectinib.”

This draft guidance is currently open for consultation until the 6th February 2020.