FDA Approves Celebrex for New Indication
December 23, 1999
Summary:
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.
On December 14, 1999, FDA's Oncology Drugs Advisory Committee recommended approval of genetic disorder. Celebrex is manufactured by Searle, Chicago, Ill.
Weitz & Luxenberg is no longer accepting Celebrex cases.
see also:
FDA Approves Celebrex
FDA Celerex ApprovalFDA Approves Celebrex for the Public to Use
Official Documents
Celebrex Public CommentOfficial Comments on the Risks and Side Effects of Celebrex
