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| |  First Biologic Drug Licensed In U.S. To Boost Platelet Production MADISON, NJ -- November 26, 1997 -- The United States Food and Drug Administration (FDA) has granted marketing clearance for Genetics Institute, Inc.’s Neumega(R)(Oprelvekin) (rhIL-11), the first biologic drug that promotes production of the body's platelet supply in cancer patients undergoing chemotherapy. By significantly reducing the incidence of severely low platelet levels, a serious side effect which often delays chemotherapy administration, Neumega may give some cancer patients a better chance of receiving the treatment they need to fight their disease. Neumega will be used for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia. In clinical trials involving 170 patients, Neumega reduced the incidence of severe chemotherapy-induced platelet depletion, reduced the need for platelet transfusions and reduced the number of platelet transfusions required. In clinical trials, apart from the condition of the underlying disease state, most adverse events associated with Neumega were mild to moderate in severity, associated with fluid retention and reversible after discontinuation of dosing. The most common adverse events associated with Neumega treatment included peripheral edema, dyspnea, tachycardia and conjunctival redness. Additionally, Neumega is undergoing a pharmacokinetic study among children with chemotherapy-induced platelet depletion. Neumega, a platelet growth factor, stimulates the production of blood platelets, which are essential to the blood-clotting process. Chemotherapy patients often develop thrombocytopenia, or a drop in the number of blood platelets. Without sufficient amounts of these blood components, doctors are often forced to reduce, delay or prematurely stop chemotherapy dosing and/or give transfusions to replenish platelets -- alternatives that can impact planned disease treatment. By decreasing the proportion of patients who require platelet transfusions, the use of Neumega may reduce the incidence of potential complications associated with platelet transfusions. In clinical studies, Neumega reduced the need for platelet transfusions while full planned chemotherapy doses were maintained. "For many patients with cancer, chemotherapy is the patient's best option for treatment. Patients want to be able to receive their full dose of chemotherapy as scheduled. Decreasing or delaying chemotherapy to allow blood cell recovery can impact a patient's treatment plan," said Michael Gordon, M.D., associate professor of medicine and director of the Clinical Hematology and Cytokine Program at Indiana University Medical Center, Indianapolis. "Neumega may give patients at risk for severe thrombocytopenia a better chance for optimal treatment by enabling physicians to administer planned chemotherapy.” Repeated cycles of dose-intensive chemotherapy may cause myelosuppression, or damage to the body's bone marrow, and may deplete blood cells including platelets -- blood components that prevent bleeding and repair damaged blood vessels. If platelet counts fall below a certain level, platelet deficiency, or thrombocytopenia results. Thrombocytopenia affects at least one in four patients undergoing chemotherapy. Of the 1.3 million new cancer patients diagnosed each year, about half undergo some form of chemotherapy. Chemotherapy-induced thrombocytopenia is currently managed by platelet transfusion and/or by reducing or delaying chemotherapy until bone marrow function recovers and platelet count increases. But reducing chemotherapy doses and delaying or stopping treatment can theoretically allow cancerous cells to grow or spread. Transfusions may put patients at risk for blood-borne infections such as hepatitis B and C, HIV, and HTLV (human T-lymphotropic virus) and can cause immune reactions, such as fever. "Neumega joins two other classes of biologic drugs -- one to stimulate red blood cells and another, white blood cells -- adding a new component to management of some side effects of chemotherapy,” Dr. Gordon said. “These agents may help improve management of the 600,000 to 800,000 cancer patients who are treated with chemotherapy each year."
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