Brexit could deny children access to cancer drug trials
Brexit could mean that children may be denied access to experimental cancer drugs, experts have said, while calling for reform of EU regulations to encourage more paediatric oncology trials.
The government expects to quit the European Medicines Agency when it leaves the EU – and this could prevent UK children enrolling on the already scarce paediatric cancer trials.
The Institute of Cancer Research, London and the Royal Marsden NHS Foundation Trust set out their concerns in a response to the European Commission’s consultation on the future of the EU Paediatric Regulation.
In the response, the organisations said that the rules on paediatric cancer trials should be changed to encourage more cancer trials in children, and applied across Europe ahead of Brexit so UK children do not lose out.
The experts are particularly concerned about waivers provided by the existing regulation that allow drug companies to opt out of running clinical trials of new cancer drugs in children, where there is good evidence that the drugs could be beneficial.
The 2007 regulation aimed to improve children’s access to new treatments – but companies can apply for the waiver if a drug targets a cancer that does not affect children, such as lung cancer.
But drugs are increasingly targeting certain genetic mutations, which could occur in adult cancers and childhood cancers.
In some cases waivers have been granted because drugs were first approved in adult cancer, even though they have a potential paediatric cancer use.
The experts cited the example of Pfizer’s drug Inlyta (axitinib) and Roche’s Gazyva (obinutuzumab), which were granted waivers despite having a mechanism of action that is potentially relevant to paediatric cancers.
Axitinib could potentially be effective in childhood neuroblastoma, hepatoblastoma, medulloblastoma, Wilms’ tumour and ependymoma. It could also have a role in rhabdomyosarcoma and high-grade glioma.
Obinutuzumab may be relevant for lymphoma, the experts said.
In an interview with the BBC, Professor Louis Chesler, honorary consultant in paediatric oncology at the Royal Marsden NHS Foundation Trusts, said the a wider rethink of regulation is necessary.
He said: “Is there any reason why adult cancer trials can’t lower their age limits to 16, or even 12?”
“Everyone realises this is a challenge, but more incentives are needed for drug companies to make a return and to speed up the development of drugs.”
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