Genetics Institute's Neumega Backed By FDA Panel

As the Marketletter predicted in a report last week (July 28), the USFood and Drug Administration Biological Response Modifiers Advisory Committee has unanimously recommended approval of Genetics Institute's platelet growth factor Neumega (recombinant human interleukin-11) for the secondary prevention of severe chemotherapy-induced thrombocytopenia and to reduce the need for platelet transfusions in patients with solid organ tumors or lymphomas who have a history of chemotherapy or transfusions.

GI, a unit of American Home Products, had hoped for a primary prevention indication. However, the committee voted 14-3 that the data failed to show as large a treatment effect in patients who had not previously received chemotherapy.

Primary Prevention Data Not Sufficient In the primary prevention, intent-to-treat trial, 68% of 40 women administered Neumega avoided transfusion, compared to 41% of 37 placebo receivers. The women had advanced or high-risk breast cancer and had not experienced thrombocytopenia in two courses of high-dose cyclophosphamide and doxorubicin. Neumega patients received an average 0.8 tranfusions, compared to an average 2.2 transfusions in placebo patients. However, the FDA committee rejected these results as there was a number of women who did not complete the study.