News
02/21/1991

<TITLE>G-CSF Approved to Protect Cancer Chemo Patients </TITLE>
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G-CSF Approved to Protect Cancer Chemo Patients 


P91-6                                       Food and Drug Administration
FOR IMMEDIATE RELEASE                       Sharon Snider - (301) 443-3285

    The Food and Drug Administration today announced approval of a new
genetically engineered drug that can reduce the number of infections in 
cancer patients who may be at high risk during chemotherapy.
    The drug, granulocyte colony-stimulating factor (G-CSF), stimulates the 
production of infection-fighting white blood cells.  These are reduced or 
destroyed during many kinds of cancer chemotherapy. 
    White blood cell counts become dangerously low in some cancer patients, 
leaving them vulnerable to life-threatening infections.  G-CSF will lessen
their chances of infection and reduce their need for antibiotics and
hospitalization, resulting in a significant improvement in the quality of 
life for these patients.
    FDA Commissioner David Kessler, M.D., said, "G-CSF is a pioneer 
therapeutic product.  Other biotechnological therapeutics have held high
promise, but proved to be useful to only a small number of patients.  G-CSF 
will be useful in treating a large number of cancer patients."
    G-CSF is indicated for use with myelosuppressive chemotherapy, a type of
chemotherapy that not only is destructive to cancer cells but to certain
immune cells as well.  Thus patients on myelosuppressive chemotherapy can 
become vulnerable to life-threatening infections.  Each year 225,000 cancer 
patients are treated with this type of chemotherapy.
                                   
                                            Page 2, P91-6, G-CSF

    G-CSF does not affect the underlying malignancy and has no proven 
benefit in enhancing survival.
    Clinical studies involving more than 350 chemotherapy patients with 
various types of cancer, including small cell lung cancer and kidney cancer,
were carried out in the United States, England and Australia.  These studies
showed that filgrastim G-CSF significantly increased white blood cell counts
(primarily white blood cells known as neutrophils), resulting in a
significant reduction in infections, need for I.V. antibiotics and the
length of the hospitalizations. 
    No serious side effects were reported in the clinical trials.  The most 
common adverse reaction, experienced by about 20 percent of patients in the 
studies, was mild to moderate bone pain.  The pain could be controlled in 
most patients with acetaminophen. 
    G-CSF is one of a group of proteins called colony stimulating factors.
The body produces and uses these factors to regulate the production of
different types of blood cells.  They are found only in tiny amounts in 
human tissue, but they can now be mass-produced by using gene-splicing
techniques. 
    HHS Assistant Secretary for Health James O. Mason, M.D., said, "FDA's 
scientists can take pride in having recognized the significance of this new 
class of biological drugs early on -- and approving filgrastim within six 
months of the final license application submission."  FDA is one of the 
Public Health Service family of health within HHS.
    In 1985, Amgen, Inc., of Thousand Oaks, Calif., succeeded in cloning the
gene for G-CSF, leading to the company's development of the drug. 
                                   
                                            Page 3, P91-6, G-CSF

    Filgrastim is manufactured by recombinant DNA technology.  It is
produced in a special laboratory strain of Escherichia coli bacteria that 
has been genetically altered by adding a gene for human granulocyte colony
stimulating factor. 
    Chemotherapy patients will be given G-CSF daily for 10 to 14 days,
beginning one to two days after their chemotherapy treatment.  The drug can 
be self-administered on an outpatient basis or given intravenously in the 
hospital or clinic. 
    Filgrastim will be marketed in the U.S. by the developer--Amgen--under
the trade name Neupogen.

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