News
05/21/1990

<TITLE>BCG for cancer</TITLE>
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BCG for cancer

P90-32                                            Food and Drug Administration
FOR IMMEDIATE RELEASE                             Eva Kemper -- (301) 443-3285

    The Food and Drug Administration today approved the use of a live, but
weakened bacteria to treat a type of cancer involving the lining cells on 
the inner surface of the urinary bladder. 
    More than 45,000 cases of bladder cancer are detected in the United 
States each year.  This type of bladder cancer -- "carcinoma in situ," the
Latin for "cancer in place" -- is found in 20 to 30 percent of the cases. 
    To treat the cancer, the live bacteria is administered at a high dosage 
directly into the bladder through a catheter to cause an inflammatory 
reaction that eliminates many of the cancer cells.  The patient holds the 
product for about two hours before urinating.  The procedure is repeated
once a week for six weeks and then monthly for six to 12 months.
    The treatment may be used alone or following surgical scraping to remove
visible tumor growth. 
    The product is called Bacillus Calmette Guerin Live (intravesical) or 
BCG Live.  Intravesical means that it is administered directly into the 
bladder via a urethral catheter instead of being injected under the skin. 
BCG Live is made by using live, but weakened, bacteria and is manufactured
by Connaught Laboratories Ltd. of Willowdale, Ontario.  Although there are
BCG vaccines currently licensed in the United States, only BCG Live 
(intravesical) produced by Connaught Laboratories has been approved for the 
                                   


                                                   Page 2, BCG Live, P90-32 
treatment of CIS of the bladder.  The Connaught Laboratories' product is not
approved for use as a vaccine.
    In controlled multicenter studies, sponsored by the National Cancer 
Institute, 74 percent of patients with CIS of the bladder responded to the
treatment.  Patients treated with BCG had a median time for recurrence of 
the cancer of four years. 
    For persons who do not respond to treatment with BCG, other treatment 
such as removal of the bladder may be recommended.
    Flu-like symptoms such as fever, chills and nausea, and discomfort
related to inflammation of the bladder are the most common side effects 
following BCG Live therapy.  However, the FDA-approved labeling also warns
physicians to watch for and treat any spread of BCG organism throughout the 
body, which has been associated with two deaths.
    BCG Live (intravesical) will be distributed by Connaught Laboratories 
Inc., of Swiftwater, Pa., under the trade name Theracys.


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