FDA Approves Vidaza Label Expansion

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals
Article Date: 22 Aug 2008 - 3:00 PDT

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The Aplastic Anemia & MDS International Foundation (AA&MDSIF) is pleased to inform patients that the U.S. Food & Drug Administration (FDA) has expanded the label for VIDAZA (azacitidine) to include data from the AZA-001 trial, which found that Vidaza is the only agent that extends survival in MDS (myelodysplastic syndromes) patients. Vidaza was also shown to delay progression to acute myelogenous leukemia (AML) in patients with MDS. Roughly 30 percent of patients diagnosed with MDS will progress to AML.

"We are very encouraged by the Vidaza data from the AZA-001 trial. This trial showed, for the first time, a drug can extend survival for MDS patients," said John Huber, Executive Director of the Aplastic Anemia and MDS International Foundation. "We are excited to see that in this trial Vidaza also reduced the need for blood transfusions."

MDS occur when the bone marrow stem cells malfunction. This results in the production of too many defective blood cells and not enough normal cells. Diagnosis is made through blood tests and a bone marrow biopsy. Once diagnosed, treatment and evaluation should occur under the care of a hematologist or hematologist/oncologist. There are many subtypes of MDS classified according to how the disease manifests itself in the blood and marrow of the patient. Treatments include blood transfusions, growth factors, chemotherapy and bone marrow transplant.

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About the Aplastic Anemia and MDS International Foundation

Founded in 1983, the Aplastic Anemia & MDS International Foundation is dedicated to serving as a resource for patient assistance, advocacy, and support. AA&MDSIF provides patients and their families with support, as well as the latest medical information. AA&MDSIF also funds research to find cures for aplastic anemia, myelodysplastic syndromes (MDS), paroxysmal nocturnal hemogloburina (PNH), and other bone marrow failure diseases. Educational and support resources are free to patients and families, the media and the general public at http://www.aamds.org/.

Source: John Huber
Aplastic Anemia & MDS International Foundation

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