Drug News
Psoriasis drug may raise cancer risk
By Jimmy Downs
Jun 14, 2008 - 11:13:42 AM

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Saturday June 14, 2008 (foodconsumer.org) -- U.S. drug reviewers said in documents released Friday that an experimental psoriasis drug called ustekinumab from Johnson & Johnson is effective at relieving symptoms, but long-term use may raise cancer, Reuters reported.

A spokesman for J&J Centocor unit said the risk was theoretical and the company planned to monitor the drug safety after the drug is put on the market.

Many types of cancer take 10-plus years to develop and many trials last for only a few years.  Because of this, no elevated risk was observed in trials does not necessarily mean the drugs are safe for a long term.

The reviewers said the FDA will ask a panel of outside advisers for advice as to whether or not animal data suggesting an elevated cancer risk should be put on the label or the company should do more research on the safety issue.

Ustekinumab injections were demonstrated in two company-sponsored trials to be effective at relieving the severity of symptoms in patients with psoriasis, a skin disorder that affects an estimated 7.5 million Americans.

The drug suppresses interleukin-12 and interleukin-23, two other immune-system proteins associated with inflammation.

Animal studies showed suppression of these proteins raised the odds of developing cancer, which the FDA reviewer said should justify putting the potential risk on the drug label.

Michael Parks, Centocor spokesman, was quoted by Reuters as saying that "the risk of malignancies with immunosuppressive therapy is theoretically possible."

If the drug is approved, it will compete with Amgen Inc and Wyeth's Enbrel and Abbott Laboratories Inc's Humira, which block an inflammation-causing protein called tumor necrosis factor (TNF).

Prescription information for these drugs includes a warning about a possible elevated risk of cancer.

The FDA is expected to make its decision whether or not to approve ustekinumab for sales in the U.S. market in September, Reuters reported.