ANSWERS
06/17/1996

<TITLE> FDA APPROVES DRUG FOR ADVANCE COLORECTAL CANCER </TITLE>
<PRE>

T96-42                                       Susan M. Cruzan
June 17, l996                                (301) 443-3285

        FDA APPROVES DRUG FOR ADVANCED COLORECTAL CANCER

     The Food and Drug Administration has approved Camptosar
(irinotecan), the second in a promising new class of antitumor
drugs, to treat metastatic colon and rectal cancer.  The new drug
is indicated for patients whose cancer has recurred or progressed
after treatment with standard, Fluorouracil (5-FU) based
chemotherapy.  The following may be used to answer questions.
     Colorectal cancer is diagnosed in about 134,000 people in
the United States each year.  The primary treatment is surgery,
with or without adjuvant chemotherapy and/or radiotherapy. 
However, the disease recurs in about 50 percent of these
patients, and 50 percent of patients have metastatic disease at
the time of initial diagnosis.  The drug 5-FU, with or without
leucovorin, a compound related to the vitamin folic acid, is
considered first line chemotherapy for patients with metastatic
colorectal cancer.  Treatment options for patients whose disease
fails first line therapy are very limited.        
     Camptosar has been granted accelerated approval -- a
regulatory mechanism that allows early approval for a product for
the treatment of life-threatening conditions for which no 
                              -More-                          Page 2, T96-42, Colorectal Cancer
acceptable alternative treatments exist, based on interim (or
surrogate) markers of effectiveness such as shrinkage of a tumor,
rather than a documented effect on survival or irreversible
morbidity or symptoms.  By allowing accelerated approval based on
effects very likely to lead to true clinical benefit, FDA is
giving patients earlier access to cancer therapies.  Accelerated
approval is coupled with the requirement that more definitive
data will be developed to show favorable effect on clinical
endpoints after approval.  FDA may withdraw the approval of
products that have received accelerated approval if postmarketing
studies fail to verify the clinical benefits.
     Camptosar is a member of the new class of drugs called
camptothecins, which work by inhibiting an enzyme called
topoisomerase-I.  Its approval was based on three open-label
phase 2 studies in patients with metastatic colorectal cancer
that recurred or progressed following 5-FU based chemotherapy. 
The studies showed that the drug reduced tumor size about 13
percent of patients (39 of 304 patients) with colorectal cancer
for an average duration of six months.       
     Side effects of the drug treatment included diarrhea, which
can be prolonged and severe and which requires supportive medical
treatment, and leukopenia (a temporary drop in white blood cell
counts), which reduces the body's ability to fight infections.
     On June 13, 1996, FDA's Oncology Drugs Advisory Committee 
                              -More-                          Page 3, T96-42, Colorectal Cancer
unanimously recommended that Camptosar be approved under the
accelerated approval regulations.  They also provided advice
regarding additional studies that should be conducted to further
evaluate the safety and effectiveness of the drug for full
marketing approval.
     Camptosar is administered by intravenous infusion.  The drug
is manufactured by Pharmacia & Upjohn Inc., Kalamazoo, Mich.
                              ####