In the November 11, 2010 issue of the NEJM, David Kuter and colleagues reported the results of an open label randomized trial comparing 52 weeks of Romiplostim (Nplate) to “standard of care” in patients with ITP ( Immune Thrombocytopenic Purpura). In this study, Romiplostim was associated with superior platelet response rates, lower rates of treatment failure, improved quality of life and even more importantly, no significantly increased adverse events compared to the standard of care.
In the “Research Regimens” section at www.oncoprescribe.com, we have a detailed write up on a previous study on Romoplostim by the same author published in Lancet 2008. The Oncoprescribe Blog also has a brief write up on the REMS program.
Romiplostim was approved by the FDA on August 22, 2008 for the treatment of thrombocytopenia in patients with chronic Immune Thrombocytopenic Purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Armed with the recently published data, it is likely that Romiplostim for ITP could be taking the front row seat.
