Current EU rules restrict access to new, potentially life-saving cancer treatments in children

IMG_0636by Jackie Turner, Macmillan Principal Pharmacist Oncology & Haematology

Around 1,600 children are diagnosed with cancer in the UK every year.

But is there enough paediatric research to allow more testing of potentially life-saving cancer drugs?  

Currently, the EU Regulations allow pharmaceutical companies to opt out of children’s trials if a new drug is intended for an adult cancer that does not occur in children.

What does this mean?

In the past, cancer treatments were defined by the tumor of origin. Opting out on drug trials for treating cancers that not occur in children was meant to protect children.

However our understanding of cancer has changed and treatment has moved on. Modern cancer treatments are often targeted at genetic features of the tumour that may be common to a number of tumour types found in both, adults and children. Alhough breast and stomach cancers do not often occur in children, there are many adult cancers that have genetic mutations that also occur in childhood cancers.

Consequently, we are now able to treat stomach cancer with a drug that was first developed to treat breast cancer.  Drugs licensed to treat lung cancer in adults can also target a genetic mutation that occurs in some children with neuroblastoma, for example, because it targets the same cell variation.

Under current legislation these drugs would not reach children because they are only licenced to be used in adults, unless a doctor prescribes it “off label” for a child. Waivers are often granted even when a drug could potentially treat tumours in children.

There are several new cancer medicines available to treat malignant melanoma, for example, an aggressive form of skin cancer. Even though the waiver was in place for children under 12 years of age, all of these medicines are only currently licensed for adult use.

This does call for an urgent change in EU regulations. They are outdated and restrict research into new, potentially life-saving cancer treatments in children and seriously resrict developments in patient care. The regulation must move on with the same pace of the phenomenal scientific development in understanding the evolution of cancer.