FDA Approves Celebrex For New Indication

FDA today approved Celebrex for a new indication  as the first drug treatment aimed at reducing the number of intestinal polyps in patients with a rare genetic disorder called familial adenomatous polyposis (FAP). Patients with FAP develop large numbers of intestinal polyps and, as a consequence, have a greatly increased risk of developing colon and rectal cancer at an early age. The following may be used to answer questions.

Celebrex, a COX-2 selective non-steroidal anti-inflammatory drug, was approved in l998 for the relief of signs and symptoms of rheumatoid and osteoarthritis. Its new indication provides a treatment for reducing the numbers of colorectal polyps in patients with FAP. It should be used only as an adjunct to usual care in managing FAP, which typically involves surgical removal of much or all of the lower intestine (colon and rectum) by early adulthood, with careful monitoring of any remaining lower intestinal tissue. It is critical that this usual care not be altered.

The drug was granted accelerated approval (for the new indication), which allows early approval of a product for treatment of a life-threatening condition for which no acceptable alternative treatments exist or which provides a meaningful therapeutic benefit over existing treatments based on a "surrogate" marker. The surrogate in this case is the number of polyps; reduced numbers appear likely to be beneficial to FAP patients, but this has not yet been proven.

The approval of Celebrex for FAP was based on a six-month placebo-controlled trial in 83 patients, sponsored, in part, by the National Cancer Institute's Division of Cancer Prevention. In the study, there was a 28 percent reduction in the number of polyps in patients receiving 400 mg: of Celebrex compared to five percent for those receiving placebo. The most common side effects were diarrhea and indigestion.

The clinical benefit of reducing the number of colorectal polyps in FAP has not been demonstrated. It is also not known whether the effect of Celebrex treatment will persist after Celebrex is discontinued. Therefore, as a condition of approval, FDA is requiring the manufacturer to conduct further studies to evaluate clinical benefit, if any, of reducing polyps in patients with this condition.