Psoriasis Drug Will be Approved Despite Cancer Concerns
An experimental Johnson & Johnson drug should be approved for treating adults with moderate or severe psoriasis despite the caner risk.
An experimental Johnson & Johnson drug should be approved for treating adults with moderate or severe psoriasis, the Food and Drug Administration advisory panel unanimously ruled.
The ability of the drug, ustekinumab, to relieve symptoms of the skin disorder outweighed concerns treatment might increase the risk of cancer, the outside experts that advise the Food and Drug Administration said.
Specifically, ustekinumab blocks interleukin-12 (IL-12) and IL-23, two immune-system proteins that promote inflammation. When the IL-12/IL-23 are blocked or removed in mice, the rodents get cancer at a higher rate.
While the patients taking ustekinumab in clinical trials didn't have an increased rate of cancer, the trials probably didn't go on long enough to see an effect.
But doctors are anxious to approve the drug, no matter what the risks.
"It's quite striking how well it works compared to other things that we have available," said panel chairman Michael Bigby, associate professor of dermatology at Beth Israel Deaconess Medical Center in Boston.
The current psoriasis drugs that inhibit a different immune-system protein called TNF -- Abbott Labs' Humira and J&J and Schering-Plough's Remicade -- already have a potential cancer risk on their label.
The FDA is also investigating whether use of the TNF inhibitors is linked to cancer in children, but the agency hasn't shown any signs of pulling them off the market.