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Kounteya Sinha,TNN | Feb 12, 2014, 05.10 AM IST
LONDON: Children with cancer are being denied entry into potentially life-saving drug trials because of loopholes in European Union regulations.
Of the 28 cancer drugs which have received authorization in Europe since 2007, 26 have the potential to work on children but 14 of them have been waived from being tested on under-18-year-olds.
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.
An analysis shows that the European Commission's alternative route for getting cancer drugs to children – its regulation on rare, or orphan conditions – is failing to be effective. Of the 25 EU-approved orphan medicinal products for cancer, none were registered for children in a different cancer type to that in adults.
ICR has now called for urgent modifications to the current system to make sure pharma companies test more of their drugs in children.
Under the current system, pharma companies often gain exemptions from carrying out expensive testing of cancer drugs in patients under the age of 18 even where a drug's mechanism of action suggests it could work in children. As a result there are significant delays in new drugs becoming available for children, and some drugs may never be formally licensed for paediatric use.
The ICR is pushing for the changes in collaboration with the European Consortium for Innovative Therapies for Children with Cancer (ITCC), based in France, and the two organizations have analysed data on the impact of current EU regulations.
Alan Ashworth, chief executive of ICR 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," he added.
Louis Chesler from ICR said, "Increasing the number of paediatric cancer trials can have enormous benefits for children with cancer by increasing the number of drugs available to them and improving doctors' knowledge about how best to use drugs in children with providing treatment in a best-practice clinical trial environment."