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| |  Thalomid (Thalidomide) Shows Promise In Myelodysplastic Syndromes WARREN, N.J. -- August 10, 2001 -- The first peer-reviewed study evaluating the potential use of Celgene Corporation’s Thalomid® (thalidomide) to treat myelodysplastic syndromes (MDS) will be published in the August 15, 2001 issue of the journal Blood. The study, titled "Thalidomide Produces Transfusion Independence in Long-standing Refractory Anemias of Patients with Myelodysplastic Syndromes," reports on 83 MDS patients treated with Thalomid. Sixteen patients experienced hematologic improvements (19 percent of intent-to-treat patients; 31 percent of evaluable patients), including 10 transfusion-dependent patients who became transfusion independent during the study. "These results, suggesting potential activity of thalidomide in myelodysplastic syndromes, warrant further clinical investigation," said Azra Raza, MD, principal investigator at Chicago’s Rush Cancer Institute. This pilot study was initiated to evaluate the activity of Thalomid in either low or high-risk patients with MDS. Patients received an initial Thalomid dose of 100 mg/day and were escalated as tolerated. Sixteen patients showed hematologic improvement with 10 patients becoming transfusion independent. Hematologic improvement was measured by increased platelets, decreased dependence on transfusions and improved erythroid series. "Based on this study, we have initiated a Phase III trial to further evaluate Thalomid as a treatment of MDS," said Jerome B. Zeldis, MD, PhD, Chief Medical Officer of Celgene Corporation. Less than five percent of patients had grade four toxicity with the most commonly reported side effects being fatigue, constipation, shortness of breath, fluid retention, dizziness, rash, tingling in fingers and/or toes, fever and headache, and nausea.
About Myelodysplastic Syndromes Myelodysplastic Syndromes are a group of conditions caused by abnormalities of the blood-forming cells in the bone marrow resulting in a shortage of blood cells and, ultimately, low blood counts. The five types of MDS are refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in formation, and chronic myelomonocytic leukemia. Approximately 50,000 patients in the United States have MDS. According to the American Cancer Society 14,000 new cases of MDS are diagnosed each year in the United States, with survival rates ranging from six months to five years for the different types of MDS.
Safety Notice Thalidomide is contraindicated in pregnant women and women capable of becoming pregnant. Even a single capsule taken by a pregnant woman can cause severe birth defects or death to an unborn baby. To minimize this risk, only prescribers and pharmacies registered with the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.®) distribution program may prescribe or dispense Thalomid® (thalidomide). Other adverse drug reactions known to be associated with thalidomide therapy include: peripheral neuropathy, a common, potentially severe side effect that may be irreversible; drowsiness/somnolence; dizziness/orthostatic hypotension; neutropenia; hypersensitivity reactions; and increased HIV-viral load. Physicians should consult full prescribing information about these and other adverse reactions prior to initiating treatment with Thalomid®. Thalomid® (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of cutaneous manifestation recurrences. Thalomid® is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis. SOURCE Celgene Corporation
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