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Cancer Experts Call for Change in EU Rules That Stop Children with Cancer from Benefiting from New Drug

Young Boy with Shaved HeadLeading cancer experts are urging the European Union (EU) to change regulations on children’s cancer drug trials, arguing that the current system denies children new, potentially life-saving drugs.

Current EU rules allow pharmaceutical companies to obtain exemptions for performing expensive drug trials in patients under the age of 18 — even despite evidence that the drug could help treat children. That drug companies can apply for such waivers causes significant delays in testing medications on patients under 18 years old. Potentially life-saving drugs are therefore never formally licensed for use in children.

Argues Professor Alan Ashworth, Chief Executive of the Institute of Cancer Research (ICR) in the United Kingdom:

“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.”

According to the ICR, 26 of the 28 drugs approved for use in adults in the EU since 2007 have anti-cancer mechanisms that could help treat children. However, 14 of the drugs could not be tested on children under current EU regulations because the conditions the drugs were developed for do not occur in children.

The ICR has teamed up with the European Consortium for Innovative Therapies for Children with Cancer (ITCC) in France to urge the EU to change current regulations to ensure that drug companies perform more trials in patients under the age of 18.

States Dr. Louis Chesler, Reader in Paediatric Solid Tumour Biology and Therapeutics at the ICR and Honorary Consultant at The Royal Marsden NHS Foundation Trust:

“Increasing the number of paediatric cancer trials can have enormous benefits for children with cancer, by increasing the number of drugs available to them, improving doctors’ knowledge about how best to use drugs in children, and providing treatment in a best-practice clinical trial environment.

“Many cancer drugs developed for adults could be effective in children if we were able to test them in clinical trials. But the current system allows drug manufacturers to avoid testing their products in children, on the flawed grounds that adult cancers don’t have direct children’s equivalents – even where there is a common mechanism of action.”

Members of the ICR argue that current regulations are denying children from potentially life-saving medications due to the lack of testing in individuals under 18 years old.

Professor Gilles Vassal, Head of Clinical Research at Gustave Roussy and Chair of the European Consortium for Innovative Therapies for Children with Cancer, states:

“The European Paediatric Medicine regulation significantly changed the landscape of drug development in children. However, there is an urgent need to change its implementation in order to meet the need for new innovative medicines to cure children and adolescents suffering life-threatening malignancies.

“Speeding up innovation is a major goal for the European paediatric oncology community. Setting up cooperation between academia, regulatory bodies, industry and parent organisations is paramount and will be a key success factor.”

Adds Paul Burstow, MP for Sutton and Cheam and former health minister, who recently co-chaired a summit meeting of leading oncologists, cancer researchers and health regulators to discuss children’s and adolescents’ access to clinical trials:

“Our scientists are doing phenomenal work understanding the evolution of cancer and how to tackle it. However, that work is being held back by rules which harm patient care. Childhood cancer is a tragic reality for thousands of families, and it makes no sense to restrict research into potentially life-saving new treatments.

“It is important that we have rules to govern the ethical pursuit of new medicines, but these rules must be grounded in scientific reality and human need.”

Cancer experts at the ICR and ITCC want the EU to make applying for age exemptions more difficult for drug companies so that more potentially life-saving medications will be tested on and licensed for use in children under the age of 18.

References

EU rules stop children with cancer benefiting from new drugs: http://www.medicalnewstoday.com/articles/272524.php
ICR press release: http://www.icr.ac.uk/press/press_archive/press_releases_2014/24538.shtml

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Young Boy with Shaved Head: http://www.freeimages.com/photo/843999

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