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

GFR genes, but the manufacturers have been granted waivers from testing the drugs in children, even though ALK and EGFR mutations have been shown to play a role in some childhood cancers.

The analysis by the ICR and the ITCC also 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.

The ICR is calling for a change in the implementation of the 2007 European Union Regulation on Paediatric Medicine, originally designed to improve children's access to new treatments.

Specifically, the ICR wants the European Commission to refuse to grant waivers to pharmaceutical companies exempting them from testing cancer drugs in children on the basis that the adult cancer targeted does not occur in children.

These so-called 'class waivers' allow pharma companies to avoid the implementation of Paediatric Investigation Plans (PIPs), which are supposed to give companies an incentive to test their products in children by offering longer market exclusivity.

Although waivers are appropriate when an adult cancer drug will not work in childhood cancers, they are often granted even when evidence shows that a drug for adult cancers has a mechanism of action that could treat childhood cancers too.

The ICR has already asked the European Commission to make changes to the implementation of the EU Regulation on Paediatric Medicine, and now plans to speak to key partners in the UK and internationally to try to secure change.

The ICR also believes in the need for stronger financial incentives to compensate pharmaceutical companies for the financial challenge of developing drugs for small patient populations. Some pharmaceutical companies already voluntarily submit PIPs based on mechanism
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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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