Arthritis Drug Approved for Polyp Prevention Blazes Trail For Other Prevention Trials

Extract

Compared to the media attention surrounding the approval of tamoxifen to reduce the risk of breast cancer in high-risk women, the approval of celecoxib for the reduction of polyps in familial adenomatous polyposis (FAP) patients was a sleeper.

But the approval of celecoxib is important for two reasons: its fast-track approval based on a noncancer endpoint and its potential to prevent more than one type of cancer.

The U.S. Food and Drug Administration approved the use of celecoxib (Celebrex™, Searle Monsanto, Skokie, Ill.) as an adjunct to usual care for patients with FAP on Dec. 23, 1999, based on the results of a National Cancer Institute-sponsored phase II/III trial in 83 patients. That trial showed that patients taking 400 mg of celecoxib twice daily for 6 months had 28% fewer polyps on average than those on a placebo. The study has been submitted to a scientific journal for publication.

In a disease where the only treatment is surgery and more surgery, a nonsurgical intervention is a potential improvement. FAP patients develop hundreds to thousands of adenomas throughout their colon and rectum, beginning in adolescence. Left untreated, nearly all patients develop colorectal cancer by their 40s and 50s.