Answers
12/27/1994

<TITLE>FDA APPROVES DRUG FOR NON-SMALL CELL LUNG CANCER</TITLE>
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T94-62                                          Susan M. Cruzan
Dec. 27, 1994                                   301-443-3285

        FDA APPROVES DRUG FOR NON-SMALL CELL LUNG CANCER

     FDA has approved the drug Navelbine for treatment of non-small
cell lung cancer.  Navelbine is indicated for use alone or in
combination with cisplatin, a commonly used cancer drug, for
ambulatory patients with advanced non-small cell lung cancer who
are not candidates for surgery because of the extent of their
disease.  The following may be useful in answering questions.
     Two studies have demonstrated that Navelbine injection, used
alone or in combination with cisplatin, prolonged patient survival
compared to other treatments.  In one randomized study, patients
treated with Navelbine had a median survival of 30 weeks compared
to 22 weeks in patients treated with an investigational combination
of leucovorin and fluorouracil (5FU), a regimen of unestablished
value.
     In a European multicenter, randomized trial, patients with
inoperable cancer given Navelbine plus cisplatin survived a median
of 40 weeks, compared to 32 weeks for patients given vindesine plus
cisplatin, and 31 weeks for Navelbine alone.
     The major side effects of Navelbine include neutropenia (a
decrease in white blood cells which increases susceptibility to
infection), weakness, inflammation or discomfort at the injection 
                             -MORE-

                                          Page 2, T94-62, Navelbine
site, nausea, vomiting, constipation, and numbness, pain or
tingling in fingers and toes.
     Under a treatment IND authorized by FDA on May 3, 1994, more
than 390 patients received the drug.  FDA's treatment IND
regulations allow drug developers to provide earlier and wider
access to promising investigational therapies for patients with
serious or immediately life-threatening disease conditions for
which there are no comparable or satisfactory alternative
treatments available.
     Burroughs Wellcome Co. of Research Triangle Park, N.C.,
manufactures the drug.
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