Answers
02/17/1995

<TITLE>FDA AUTHORIZES TREATMENT IND FOR ADVANCED PANCREATIC CANCER</TITLE>
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T95-10                                     Susan M. Cruzan
Feb. 17, l995                              (301) 443-3285

   FDA AUTHORIZES TREATMENT IND FOR ADVANCED PANCREATIC CANCER

     FDA has authorized a treatment IND (investigational new drug)
for gemcitabine HCL for patients with advanced pancreatic cancer
who are not candidates for surgery.  The following can be used to
answer questions.
     FDA's treatment IND regulations offer a mechanism that allows
drug developers to provide earlier and wider access to
investigational therapies for patients with immediately life-
threatening or otherwise serious diseases for which there is no
satisfactory alternative treatment, while review of the new drug
application for the same indication is completed.
     About 27,000 people in the United States were diagnosed with
pancreatic cancer in l994.  Pancreatic cancer is generally
asymptomatic until late in the course of the disease.  It is among
the most difficult cancers to treat and is rarely curable.  
     FDA authorized the treatment IND for gemcitabine to provide a
promising treatment of locally advanced or metastatic pancreatic
cancer.  Patients may have had either one prior chemotherapy
regimen or none.  No therapies have been approved specifically for
this disease.
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                                   Page 2, T95-10, gemcitabine
     A preliminary review by FDA of two clinical trials of
gemcitabine suggests that it may have some effectiveness in the
treatment of this disease.  The sponsor, Eli Lilly and Co. of
Indianapolis, Ind., carried out two trials in patients with
pancreatic cancer, one a comparison with 5 fluorouracil (5-FU) in
previously untreated patients; the other a study in 5-FU failures. 
The studies measured tumor shrinkage, survival and an overall
estimate of clinical benefit (pain and ability to function).  
     Both studies showed a small rate of tumor shrinkage (about 7
percent); there was a small (about one and a half months)
improvement in median survival in the study comparing gemcitabine
with 5-FU.  In both studies gemcitabine treated patients
experienced an approximately 25 percent rate of clinical response. 
The 1 year survival rates in the comparative trial were 18 percent
and 2 percent for gemcitabine and 5-FU respectively.   
     A second phase II trial included patients who had not
responded to 5-FU treatment.  Symptoms improved in 27 percent of
patients, with a median survival time of 3.85 months and a one year
survival rate of 4 percent.  A partial response rate (50 percent or
greater decrease in tumor size) was observed in 7.9 percent with
disease stabilization reported in 31.7 percent. 
     The major side effects of gemcitabine included neutropenia, a
decrease in white blood cells, which increases susceptibility to 
infection; thrombocytopenia, a decrease in blood platelets, which
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                                   Page 3, T95-10, gemcitabine
can cause excessive bleeding; and elevation of liver enzymes. 
Nausea, vomiting, rash, flu-like symptoms, breathing difficulties
and traces of blood and protein in the urine have been reported. 
Rarely, hemolytic-uremic syndrome (anemia associated with kidney
failure) was reported.    
     The drug is manufactured under the trade name Gemzar.
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