Children with cancer 'denied drugs because of EU rules'

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EU rules must be changed to allow more testing of potentially life-saving cancer drugs on children, say experts.

The UK's Institute of Cancer Research (ICR) says the current system acts as a disincentive to drug companies who can seek waivers to avoid doing the trials.

Of 28 new cancer drugs approved in the EU for adults since 2007, 26 could potentially work in children, but 14 have been exempted from child testing.

The ICR wants these "class waivers" to be scrapped.

Start Quote

It's essential that ground-breaking cancer treatments are tested not only in adults but also in children, whenever the mechanism of action of the drug suggests they could be effective”

End Quote Prof Alan Ashworth ICR chief executive

The European Commission is considering whether to change its guidelines.

The ICR says the EC should no longer grant pharmaceutical companies exemptions on the basis that the adult cancer that the drugs treat does not occur in children.

Although waivers are appropriate when an adult cancer drug will not work in childhood cancers, says the ICR, they are often granted even when a drug has a broader action and could potentially treat childhood tumours.

For example, drugs have been approved for treating adult cancers linked to certain gene mutations, but the manufacturers have been granted waivers from testing the drugs in children who have cancers linked to the same gene errors.

Under current legislation, drug companies are offered longer market exclusivity if they test their products in children. But the ICR says too few take up this incentive.

ICR chief executive Prof Alan Ashworth said: "It's essential that ground-breaking cancer treatments are tested not only in adults but also in children, whenever the mechanism of action of the drug suggests they could be effective. That requires a change to EU rules, since the current system is failing to provide children with access to new treatments that could add years to their lives.

"Modern cancer treatments are often targeted at genetic features of the tumour that may be common to a number of tumour types, and to adults' and children's cancers. That means a drug developed for a cancer in adults could also be effective against a cancer affecting a completely different part of the body in children. The way EU rules are implemented fails to take this into account."

Once a treatment is licensed for adult use, a doctor can chose to prescribe it "off-label" to a child. But without enough trial evidence to support its use, healthcare providers may not want to pay for it.

Around 1,600 children are diagnosed with cancer every year in the UK.

A spokesperson for the National Institute for Health and Care Excellence, which sets guidelines for the use of NHS treatments in England and Wales, says all children and young people with cancer should be offered the opportunity to enter any clinical research trial for which they are eligible, and adequate resources should be provided to support such trials.

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