The NHS in England is close to approving its first histology independent cancer treatment, regulators said today.
The first drug proposed for approval was rejected today because of cost – but the National Institute for Health and Care Excellence said a second drug could be approved if it gets a European licence.
The drugs are designed to target specific genomic mutations common to many solid tumours – allowing their deployment in a range of cancers.
Bayer’s larotrectinib was refused approval today because of cost. The second drug, Roche’s entrectinib, is waiting for a preliminary decision from the European Medicines Agency.
Larotrectinib targets NTRK gene fusions, which are found in slightly under 1% of common tumours and are more common in many rare cancers.
Meindert Boysen, from 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.
“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 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."
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