TNF blockers must carry children’s cancer warning
pharmafile | August 7, 2009 | News story | Research and Development, Sales and Marketing | FDA, RA, TNF
The FDA has ruled that TNF blocker drugs should carry new warnings of the increased risk of certain cancers for children and adolescents taking the treatment.
The FDA reached the conclusion after a year-long review of data, and found that the drugs raised the risk of lymphoma and other cancers. It also identified new safety information showing some patients developed leukaemia and new-onset psoriasis.
The regulator ruled that the increased risk was not serious enough to require restrictions or withdrawal of any of the drugs.
But the new warnings could dampen the spectacular growth the TNF blocker class has enjoyed.
There are five tumour necrosis factor (TNF) blockers on the market Amgen/Wyeth's Enbrel, J&J/Schering-Plough's Remicade, Abbott's Humira, UCB's Cimzia and J&J's Simponi.
The drugs are licensed to treat juvenile rheumatoid arthritis, Crohn's disease, and other inflammatory diseases in children and adolescents. They already carry warnings about malignancies, but these do not specifically mention leukaemia.
Amgen and Wyeth insisted Enbrel "continues to offer a favourable benefit-risk relationship for patients with the diseases for which it is indicated to treat".
Analysis of US reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer – some fatal – after an average 30 months of treatment. Half of these were lymphomas, a cancer involving cells of the immune system.
Remicade and Enbrel were the two drugs most closely associated with this effect, as they are most commonly used in children.
TNF blockers target tumour necrosis factor-alpha, a protein that can cause damage to bones, cartilage and tissue in sufferers from chronic inflammatory diseases.
The FDA says it is also working with manufacturers "to explore new ways to further define" the risk of cancer in children and adolescents who use these drugs.
Two drugs have only recently joined the market. Johnson & Johnson's Simponi (a second-generation follow up to Remicade) was approved in the US in April, in combination with methotrexate, for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Meanwhile UCB's Cimzia received a positive opinion from the Committee for Medicinal Products for Human Use for rheumatoid arthritis as recently as last month.
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