An experimental psoriasis drug from Johnson & Johnson
may raise the risk of cancer,
U.S. drug reviewers said in documents recently released.
"Long-term use of ustekinumab may lead to increased
risk of tumor development in psoriasis
patients," Food and Drug Administration reviewers wrote
in an analysis prepared for an advisory panel that is
set to discuss the drug next week.
A spokesman for J&J's Centocor unit said the risk
of cancer could be just theoretical and the company
planned to monitor long-term safety after approval.
The FDA will ask the panel of outside advisers if it
would be adequate to note animal data suggesting a cancer
risk on the prescribing instructions for ustekinumab,
or if the company should do more studies, the reviewers
said.
An estimated 7.5 million Americans have psoriasis,
a skin disorder that causes scaly red patches.
Two company-sponsored trials showed ustekinumab injections
were effective at reducing the severity of psoriasis
symptoms, the FDA reviewers said.
If approved, ustekinumab would compete with other leading
injectable drugs -- Amgen Inc and Wyeth's Enbrel and
Abbott Laboratories Inc's Humira -- as well as J&J's
Remicade, which is given by intravenous infusion.
Those drugs work by blocking an inflammation-causing
protein called tumor necrosis factor (TNF).
Ustekinumab blocks interleukin-12 and interleukin-23,
two other immune-system proteins linked to inflammation.
The FDA reviewers said animal studies showed blocking
those proteins raised the chances of developing cancer,
which was enough to justify including those findings
on the drug label "to inform prescribers about
the potential carcinogenic risk."
Centocor spokesman Michael Parks said "although
the occurrence of malignancies were comparable to placebo
in clinical trials for ustekinumab, the risk of malignancies
with immunosuppressive therapy is theoretically possible."
Prescribing information for the TNF-blocking drugs
warn about a possible risk of cancer. The FDA said earlier
this month it was investigating if those medicines were
linked to cancer cases reported in children and young
adults.
The FDA is expected to make a decision on whether to
approve ustekinumab by September. The agency usually
follows panel recommendations.