The Food and Drug Administration (FDA) is to investigate a possible association between anti-TNF therapies and childhood cancer. Tumour Necrosis Factor (TNF) blockers have become the latest drug class to undergo a detailed FDA safety review, with the potential link between these agents and cancer, particularly in children and young adults, to be assessed. Although the review could increase prescribing caution of anti-TNF therapies for children in some physicians, ultimately it will not affect the use or sales of these agents in the near-term.

The FDA, which has become increasingly safety conscious in recent years, has announced that it will investigate the possible risk of cancer in children and young adults who are receiving treatment with anti-TNF therapies. There are currently four TNF therapies available in the US: Wyeth’s and Amgen’s Enbrel (etanercept), Centocor’s Remicade (infliximab), Abbott’s Humira (adalimumab) and UCB’s Cimzia (certolizumab pegol), the last of which was recently approved in April 2008.

The anti-TNFs have been available for around ten years and have proved to be a successful drug class in the treatment of autoimmune disorders. A new report estimated that the TNF class achieved total sales of around $10 billion in the seven major markets in 2007; around 75% of the sales came from the US market.

However, during this ten year timeframe, use of TNF blockers in children has yielded 30 cases of cancer including leukemias and melanomas. About half the reported cases were Hodgkin’s and non-Hodgkin’s lymphomas but it is also important to point out that the child patients received concomitant immunosuppressants such as methotrexate, azathioprine or 6-mercaptopurine, which carry a known cancer risk. The FDA will review the cancer risk over six months, but UCB will need to provide long-term safety data for Cimzia, which it will run from 2009 for 10 years, as there is currently a lack of data because it is a new product.

Fore more information see The Cancer Market Outlook to 2012