Cancer experts warn that if changes are not made to European Union regulations soon, many children with a life-threatening condition will die as a result of not receiving the right medication. The Institute of Cancer Research (IRC) is calling for a change to EU rules that prevent children from receiving cancer drugs simply because they have not been tested on patients over the age of 18.
“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,” CEO of the IRC, Professor Alan Ashworth, said in a statement. “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.”
After analyzing data surrounding the current EU cancer drug regulations, the IRC and its partner the European Consortium for Innovative Therapies for Children with Cancer (ITCC) have asked the pharmaceutical companies to include young patients in clinical testing. The adult marketing authorization in Europe has approved 28 cancer drugs since 2007 and 26 have proven effective for pediatric cancer patients. However, 14 of these drugs have been waived from being tested on patients under the age of 18 because the malady it’s supposed to treat is not found in children.
“Many cancer drugs developed for adults could be effective in children if we were able to test them in clinical trials,” explained Dr. Louis Chesler, Paediatric Solid Tumour Biology and Therapeutics at the ICR and Honorary Consultant at The Royal Marsden NHS Foundation Trust. “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.”
Under the 2007 European Union Regulation on Pediatric Medicine, so-called “class waivers” allow pharmaceutical companies to avoid implementing Pediatric Investigation Plans (PIPs). PIPs give companies financial incentive to test cancer drugs on people under the age of 18. Even if there is solid evidence proving the drug’s effectiveness on children, approving the drug would take away from financial gain while placing more of a risk on the company, Reuters reported.
“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,” said Professor Gilles Vassal, head of clinical research at Gustave Roussy and chair of the European Consortium for Innovative Therapies for Children with Cancer. “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.”
The IRC and ITCC have already asked the EU to make appropriate changes to the Regulation on Pediatric Medicine so that cancer drugs will be more readily available for children. Both groups hope to see an increase in financial rewards for companies that dare to test their developing drugs on young patients. They have also asked 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.”
“Our scintists 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,” explained Paul Burstow, MP for Sutton and Cheam and former health minister. “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.”