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The U.S. Food and Drug Administration (FDA) has approved the use of Nplate® (romiplostim) for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) that does not respond to standard therapies.

Thrombocytopenia occurs when platelet levels fall below normal. It can often occur as a direct result of cancer, from cancer treatment, or from other diseases such as ITP. Adult chronic ITP is an autoimmune disorder that results in low levels of platelets. The immune system of patients with ITP either attacks mature platelets or attacks the cells in the body that produce platelets. As a result patients with chronic ITP constantly suffer from thrombocytopenia.

Patients with thrombocytopenia may require transfusions of platelets from donors-a procedure associated with such disadvantages as medical costs, time, a potential reaction to the donor platelets, and potential infection. In addition, optimal treatment doses and scheduling for other diseases may have to be altered in patients with thrombocytopenia, which reduces the chances of optimal outcomes. To avoid these undesirable consequences, researchers have been evaluating ways to stimulate the body to produce platelets and reverse thrombocytopenia among patients with ITP and other diseases such as cancer.

Prior to the approval of Nplate, the only agent approved for the treatment of thrombocytopenia was Neumega® (oprelvekin), although it is was not widely used for the treatment of thrombocytopenia because overall results had not been promising.

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Nplate is an agent that stimulates the production of platelets in the bone marrow (spongy material inside bones), using a different pathway from Neumega. Nplate has demonstrated a significant reduction in thrombocytopenia among patients with ITP and cancer and continues to be evaluated in various diseases for both its effectiveness and its long-term safety.

The approval of Nplate is for the treatment of ITP; however, it is possible that future approvals for this agent may include thrombocytopenia in cancer patients, depending upon results from future clinical trials evaluating its use for this indication.

Reference: United States Food and Drug Administration. FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts [press release]. Available at:. Accessed August 2008.

Related News:ODAC Recommends Approval of Nplate (7/7/2008)

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