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EU rules are denying children latest cancer drugs
Date:2/10/2014

Children with cancer are being denied new, potentially life-saving drugs, because EU rules are allowing companies to trial some drugs only in adults, leading cancer experts warn today.

Changes to how EU rules are implemented could allow children access to a goldmine of potential cancer drugs which have currently only been tested in adults by making it more difficult for pharma companies to avoid testing them in under-18s too.

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 Institute of Cancer Research, London one of the world's leading centres for research into paediatric cancers today calls for urgent modifications to the current system to make sure pharma companies test more of their drugs in children.

The Institute of Cancer Research (ICR) is urging the EU to scrap the current system of waivers and exemptions which is preventing many drugs from reaching children, even when there is evidence that the drugs could be effective.

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 organisations have analysed data on the impact of current EU regulations.

Of 28 cancer drugs approved for adult marketing authorisation in Europe since 2007, 26 have a mechanism of action relevant for paediatric malignancies, but 14 have been waived from being tested in under-18s because the specific adult condition for which the drug is developed does not occur in children.

For example, drugs have been approved for treating adult cancers with mutations in the ALK or E
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Contact: Henry French
claire.bithell@icr.ac.uk
020-715-35380
Institute of Cancer Research
Source:Eurekalert

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