FDA To Fast-Track Genetics Institute's Neumega

The US Food and Drug Administration is fast-tracking its review ofGenetics Institute's Neumega, an agent to reverse the effects of cancer chemotherapy regimens which result in severe blood platelet depletion.

Neumega is a genetically-engineered version of interleukin-11 and stimulates the production and growth of megakaryocytes, precursors to platelets. The product reduces the need for platelet transfusions and helps patients safely tolerate higher doses of chemotherapy.

Phase II Data Submitted GI, a unit of American Home Products, is expected to present results of two Phase II trials: an analysis of 62 breast cancer patients who completed two cycles of platinum-based chemotherapy as out-patients revealed that only 21% of the Neumega-treated group needed platelet transfusions, compared to 52% in the placebo group. This represents a 60% reduction in the need for transfusions, according to the company. The findings were consistent across all subgroups of patients, the company adds.