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. ####