February 11, 2014
Children In The EU Denied Cancer Treatments Due To Regulations
Lee Rannals for redOrbit.com - Your Universe Online
Leading cancer experts said that EU rules are causing some children with cancer to be denied potentially life-saving drugs because the guidelines only allow companies to trial some drugs only in adults. The experts believe that changes to these rules could allow children access to high potential cancer drugs that have only been tested in adults.
With current regulations in place, pharmaceutical companies are unable to carry out expensive testing of cancer drugs in patients under the age of 18, even if a drug’s mechanism of action suggests it could work effectively in a child. These rules mean that these drugs are taking a while before becoming available to children, and some of the treatments may never even be formally licensed for pediatric use.
ICR says it is pushing for changes in the EU rules, along with the European Consortium for Innovative Therapies for Children with Cancer (ITCC). The cancer experts said they are urging the EU to scrap the current system of waivers and exceptions preventing children from access to these drugs.
According to the ICR, 26 of the 28 cancer drugs approved for adult marketing authorization in Europe have a mechanism of action relevant for pediatric ailments. However, 14 of these drugs have been waived from being tested in those under 18 because the specific adult condition for which the drug is developed does not occur in children.
Drugs that have been approved for treating adult cancers with mutations in the ALK or EGFR genes are unable to treat children, even though these mutations have been shown to play a role in some childhood cancers.
"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,” Dr Louis Chesler, Reader in Paediatric Solid Tumour Biology and Therapeutics at The Institute of Cancer Research, London, and Honorary Consultant at The Royal Marsden NHS Foundation Trust, said in a statement.
"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,” Chesler added.
Professor Gilles Vassal, Head of Clinical Research at Gustave Roussy and Chair of the European Consortium for Innovative Therapies for Children with Cancer, said the need for the changes to EU regulation is urgent.
"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,” Vassal said.