Answers
05/03/1994

T94-25                                       Susan M. Cruzan
May 3, l994                                  (301) 443-3285

<TITLE>FDA APPROVES TREATMENT IND FOR NON-SMALL CELL LUNG CANCER</TITLE>
<PRE>

    FDA APPROVES TREATMENT IND FOR NON-SMALL CELL LUNG CANCER

     FDA has authorized a "treatment IND" for the investigational
drug Navelbine for ambulatory patients with advanced non-small cell
lung cancer who are not candidates for potentially curative
regional therapy (for example, surgery  or radiation therapy) or
whose disease has spread to other organs of the body.  The
following may be used to answer questions.
       Surgery and radiation for treatment of three main kinds of
non-small cell lung cancer -- squamous cell carcinoma,
adenocarcinoma and large cell carcinoma -- can cure some patients
with localized disease.  However, patients with advanced local or
metastatic disease generally cannot be cured.  FDA authorized the
treatment IND for Navelbine because clinical trials showed
increased survival time in patients on the drug.   
     FDA's treatment IND regulations offer a mechanism that allows
drug developers to provide earlier and wider access to promising
investigational therapies for patients with life-threatening or
otherwise serious diseases for which there is no satisfactory
alternative treatment.
     Two studies have demonstrated that Navelbine injection, used
alone or in combination with cisplatin, was slightly more effective
                             -MORE-

                                   Page 2, T94-25, Navelbine
than 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 unestablished regimen of other
cancer drugs (leucovorin plus fluorouracil (5FU)).     
     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), inflammation or discomfort at injection site, nausea,
vomiting, constipation, and numbness or pain in fingers and toes. 
     On Dec. 15, l993, FDA's Oncologic Drugs Advisory Committee
recommended approval of Navelbine for treatment of ambulatory
patients with metastatic non-small cell lung cancer and in
combination with cisplatin in ambulatory patients with advanced
disease.
     Burroughs Wellcome Co. of Research Triangle Park, N.C.,
manufacturers the drug. 
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