FDA
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Food and Drug Administration
U.S. Department of Health and Human Services
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FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 


T97-60                       Lenore Gelb:         301-827-6242
Nov. 25, 1997                
                             Consumer Inquiries:  800-532-4440


        NEW BIOTECH PRODUCT APPROVED TO REDUCE NEED FOR  
            CHEMOTHERAPY-RELATED PLATELET TRANSFUSIONS

     FDA today approved interleukin eleven (IL-11), a new
bioengineered product that can reduce the need for frequent
platelet transfusions following high-dose chemotherapy.  Patients
who have required platelet transfusions after chemotherapy in the
past may benefit most from this new product. 
     IL-11 belongs to a family of human growth factors which
stimulate the growth of cells.  It is administered as a daily
injection under the skin when chemotherapy is completed.  The
genetically engineered version will be marketed under the trade
name Neumega by Genetics Institute, Inc., Cambridge, Mass.
     Platelet transfusions, while very safe, carry small risks of
infectious disease transmission, as do other blood products.  In
addition, since platelets must be stored at room temperature,
there is a small risk of bacterial contamination.  Also,
transfusions often need to be repeated frequently in an inpatient
setting, and may delay chemotherapy, causing inconvenience to the
patient.
     IL-11 is not effective for patients undergoing bone marrow 
transplants.
     In the main clinical study of IL-11, patients who had
required platelet transfusions as a result of chemotherapy were
evaluated.  In the group treated with IL-11 before receiving
another dose of chemotherapy, 28% were able to avoid platelet
transfusions compared to only 3% in the untreated (placebo)
group.
     IL-11 is known to cause fluid retention, which may in turn
cause swelling and shortness of breath when patients are
receiving the product.  Fluid retention may also be a serious
problem for patients who have or are susceptible to congestive
heart failure.  
     In addition, irregular or abnormal heart rhythms have
occurred in approximately 10% of patients receiving IL-11.
However, these problems usually did not last long and patients
returned to normal heart rhythms once the treatment ended.
Patients with these side-effects also tended to have other risk
factors including advanced age or the use of heart medications.   
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