News
06/20/1990

<TITLE>Levamisole Approved </TITLE>
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Levamisole Approved 
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P90-34                                            Food and Drug Administration
FOR IMMEDIATE RELEASE                             Eva Kemper -- (301) 443-3285

    The Food and Drug Administration today approved a combination drug
therapy to treat some advanced cases of colon cancer, second only to lung 
cancer as a cause of cancer deaths. 
    Levamisole -- a drug which has had a previous veterinary use for
eliminating intestinal parasites -- was approved for use in combination with
a previously approved cancer drug, fluorouracil, for patients who have
undergone surgery for  colon cancer, in which the cancer has spread to
nearby lymph nodes.  (This is called stage III or Dukes' C colon cancer). 
    Greg Burke, M.D., director of FDA's division of oncology and pulmonary
drug products, said, "The combination therapy is a promising advance in the 
treatment of certain patients with colon cancer.  FDA has been active in
making this therapy available rapidly to patients who may benefit." 
    Michael Friedman, M.D., associate director of the Cancer Therapy
Evaluation Program of the NCI, said the postoperative combination of
fluorouracil and levamisole is "an important advance" because it may reduce 
the risk of tumor recurrence and death in certain patients.  "However," he
added, "continued clinical trials are absolutely necessary to build on this 
advance and to further improve treatment."
                                   



                                            Levamisole, P90-34 Page 2 
    About 21,000 of the 110,000 Americans diagnosed each year with colon
cancer are at stage Dukes' C.  They have had a five-year survival rate after
surgery of only about 40 percent. 
    Scientists do not yet understand what makes the levamisole and
5-fluorouracil combination effective.  But, in two large clinical trials
sponsored by the National Cancer Institute, use of the drug combination 
following surgery reduced the death rate for patients with stage III or 
Dukes' C colon cancer by about one-third and the recurrence rate by about 40
percent.
    In the therapy, levamisole tablets are given orally for three 
consecutive days every other week and fluorouracil is given intravenously 
once a week.  The treatment is continued for a year.
    The most common side effects of the treatment are nausea, occasional
vomiting, headache, diarrhea, sores in the mouth and depression of blood
count.  Agranulocytosis, a blood disorder, has also been associated with the
treatment and caused one death among the more than 1,000 patients who 
received the combination in the NCI trials.  Because of this, patients must 
have regular blood tests. 
    Fluorouracil has been approved for the palliative treatment of cancer of
the colon, rectum, breast, stomach and pancreas.  Levamisole has been used
to treat intestinal worms in domestic animals and, until today's approval,
was commercially available in the United States only for veterinary use.
    Levamisole was developed by screening thousands of compounds for
activity against worms in animals and man.  It was synthesized in 1966 and
developed as an anthelmintic, a treatment for parasites, by Janssen 
                                   



                                            Levamisole, P90-34 Page 3 
Pharmaceutica of Beerse, Belgium.  According to the developers, it works by 
paralyzing intestinal worms so that they are passively eliminated.
    The drug began to be studied as a cancer treatment after scientists 
observed changes that intrigued them in the animals treated for parasites.
    Levamisole is manufactured by Janssen Research Foundation of Piscataway,
N.J., and will be marketed under the trade name Ergamisol.
    Levamisole has been available since May 1989 under FDA's Treatment IND
program (which releases promising but still-experimental drugs to desperate 
patients) and through the National Cancer Institute's Group C cancer
treatment program.  More than 4,000 patients with Dukes' C colon cancer have
received the combination treatment under these programs since May 1989. 
    FDA said data do not show benefit from either levamisole or fluorouracil
alone for resected colon cancer.  Although a few reports have claimed that
levamisole alone had positive effects in some cancers, other studies have 
shown that levamisole by itself is not effective in treating cancer.  The 
combination therapy has not yet been shown effective at other stages of 
colon cancer. 
    NCI-supported clinical trials are now underway to test other active 
chemotherapy combinations, such as fluorouracil and leucovorin, or active 
immunotherapy, compared to fluorouracil and levamisole, for the 
postoperative treatment of colon cancer.  Several thousand physicians 
nationwide are participating. 
    A similar clinical trial is being conducted for patients with cancer of 
the rectum to determine if the benefits seen with colon cancer extend to
this closely related cancer.

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