Oncoprescribe Blog: More on Romiplostim for ITP

November 15th, 2010

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.

Oncoprescribe Blog: REMS for Romiplostim (Nplate®) and Eltrombopag (PROMACTA®)

April 7th, 2010

The approval of Romiplostim (Nplate®), as well as Eltrombopag (PROMACTA®) included a mandatory Risk Evaluation and Mitigation Strategy (REMS) for the following reasons. There has been some concern raised with regards to long term risks associated with TPO receptor agonists, in particular bone marrow reticulin formation and risk for bone marrow fibrosis. These adverse events however were not noted in the phase III clinical trials. The Risk Evaluation and Mitigation Strategy is intended to ensure that the product is safely used with proper informed consent. It is therefore mandatory that all parties including the prescribers, patients, as well as institutions and pharmacies that wish to provide these drugs, register through the Nplate NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) program for Romiplostim (Nplate®) and  through PROMACTA® CARES for Eltrombopag (PROMACTA®) respectively. These patient registries are meant to monitor long term safety of these agents. REMS will soon be be mandated for ESA’s as well.

Oncoprescribe Blog: PROMACTA® (Eltrombopag) for Chronic ITP

January 31st, 2010

The long-term safety and efficacy of (PROMACTA® (Eltrombopag) was evaluated in an open label phase III extension study (EXTEND STUDY) and this study demonstrated that Eltrombopag (PROMACTA®) given for up to two years appears to have consistent benefit in raising the platelet counts without any significant adverse events. A new paradigm has emerged with the availability of a new class of agents such as PROMACTA®, targeting platelet production. Additional trials are underway evaluating the role of this agent in chemotherapy induced thrombocytopenia as well as Myelodysplastic Syndromes and the results are eagerly awaited with renewed interest.