Pharmacoepidemiology Roundtables  1998-1999


New Safety Issues in the Clinical Development of Platelet Growth Factors.

Jim Kaye, M.D.

ABSTRACT
Neumega (oprelvekin; interleukin 11) is the first platelet growth factor to have been licensed anywhere in the world.  Discovered in a collaboration between Children's Hospital and Genetics Institute, Inc., Neumega is approved in the U.S. to decrease the need for platelet transfusions in patients undergoing myelosuppressive chemotherapy who are at high risk of developing severe chemotherapy-induced thrombocytopenia.

Several unusual safety issues arose during the clinical development of this multifunctional cytokine, including induction of a biochemical "acute phase" response, hemodilutional anemia, and an increased risk of atrial
arrhythmias.  Other thrombopoietic growth factors still in clinical development, including Amgen's "Megakaryocte Growth and Development Factor" and Genentech/Pharmacia-Upjohn's "Thrombopoietin" have been associated with other unexpected toxicities.  The approaches to understanding novel adverse events caused by thrombopoietic growth factors will be discussed.  Much work remains to design safer platelet growth factors and to develop cancer therapies that do not cause severe myelosuppression.
 
 


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