ANSWERS
09/24/1996

<TITLE> FDA APPROVES NEW BRAIN CANCER TREATMENT </TITLE>
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T96-64                                          Susan Cruzan
September 24, 1996                              (301) 443-3285


             FDA APPROVES NEW BRAIN CANCER TREATMENT

     FDA has approved Gliadel, a wafer impregnated with an
anticancer drug, carmustine, for use as an implant after surgical
removal of a recurrent tumor of glioblastoma multiforme, an
aggressive form of brain cancer.  Gliadel wafers which are
implanted in the brain, are a new means of delivering cancer
therapy directly to the tumor site with less exposure to the rest
of the body.  The following may be used to respond to questions. 
     It is estimated that about 8,000 individuals in the United
States each year are diagnosed with a brain cancer called malignant
glioma.  Glioblastoma multiforme, which occurs primarily in adults,
is an especially aggressive type of malignant glioma.  It has
proved extremely difficult to treat effectively using conventional
cancer therapies such as surgery and radiation, with or without
chemotherapy.  
     Gliadel was approved based on the results of a multi-center
placebo controlled study in 222 patients who had recurrent
malignant glioma after initial treatment with surgery and radiation
therapy.  Following surgery to remove the tumor, half of the
patients were treated with Gliadel implants and half with placebo. 
In patients with glioblastoma multiforme, the six month survival 
rate increased from 36 percent with placebo to 56 percent with
Gliadel.  Median survival increased from 20 weeks with placebo to
28 weeks with Gliadel.  In patients with pathologic diagnoses other
than glioblastoma multiforme, Gliadel had no effect on survival.  
     The results were supported by a small study conducted in 32
patients who received either Gliadel or placebo after undergoing
initial surgical resection and radiation for malignant glioma.
     Gliadel wafers are implanted into the cavity left in the brain
after surgical removal of the brain tumor.  The wafers deliver the
active drug carmustine directly to the affected area of the brain.
     Depending on the size of the cavity, 7 to 8 wafers are
implanted.  Each wafer is 1.45 cm in diameter, 1mm thick and
contains 7.7 milligrams of carmustine -- resulting in a 61.6 mg
dose when eight wafers are implanted.  
     Following implantation, patients should be monitored closely
for possible complications such as seizures, infections, abnormal
wound healing and swelling of the brain.     
     FDA's approval follows a June 15, l996 recommendation by the
agency's Oncologic Drug Advisory committee.  Gliadel was made
available to patients with recurrent malignant glioma under a
Treatment IND which was allowed to proceed in October l995. 
     Gliadel is manufactured by Guilford Pharmaceuticals Inc.,
Baltimore, MD. 
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