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Leukaemias
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my personal edition > leukaemias > news
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DGNews
Dacogen(TM) (Decitabine) for Injection Receives U.S. Orphan Drug Designation for Patients With Acute Myeloid Leukemia
MINNEAPOLIS, MN -- August 10, 2006 -- MGI Pharma, Inc. today announced that the United States Food and Drug Administration (FDA) has granted Dacogen(TM) (decitabine) for Injection orphan designation for the indication of acute myeloid leukemia (AML).
Dacogen was approved by the FDA on May 2, 2006 for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia), and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System (IPSS) groups.
Orphan drug designation was designed to promote the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 people per year in the U.S., and may provide seven years of market exclusivity following FDA approval. Dacogen was previously designated as an orphan drug in the U.S. for the MDS indication.
Dacogen is being co-developed by MGI Pharma and Janssen-Cilag, a Johnson & Johnson company. Janssen-Cilag companies are responsible for regulatory and commercial activities in all territories outside North America, while MGI PHARMA retains responsibility for all activities in the United States, Canada and Mexico.
About Dacogen(TM) (Decitabine) For Injection
Dacogen is a hypomethylating agent that is believed to exert its antineoplastic effects by incorporation into DNA and inhibition of an enzyme called DNA methyltransferase.
Methylation is a process in which methyl (CH3) groups are added to DNA, resulting in the inactivation of genes that are critical for control of cellular differentiation and proliferation. Abnormal methylation, which silences certain genes, is associated with the development of many types of tumors.
Dacogen-induced hypomethylation in neoplastic cells may restore normal function to genes that are critical for the control of cellular differentiation and proliferation. In rapidly dividing cells, the cytotoxicity of Dacogen may also be attributed to the formation of covalent adducts between DNA methyltransferase and decitabine incorporated into DNA. Non-proliferating cells are relatively insensitive to Dacogen.
Dacogen may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while using Dacogen. Men should be advised not to father a child while receiving treatment with Dacogen and for two months afterwards.
The most commonly occurring adverse reactions with Dacogen include neutropenia (90%), thrombocytopenia (89%), anemia (82%), pyrexia (53%), fatigue (48%), nausea (42%), cough (40%), petechiae (39%), constipation (35%), and diarrhea (34%). Please visit www.mgipharma.com for full prescribing information.
MGI Pharma is currently conducting a phase 3 pivotal trial to evaluate Dacogen in patients with AML. Additional phase 2 studies are also underway to evaluate alternative dosing regimens for Dacogen in patients with MDS, AML and chronic myelogenous leukemia, or CML. A phase 3 European Organization for Research and Treatment of Cancer- (EORTC-) sponsored study of Dacogen in patients with MDS is ongoing in Europe.
SOURCE: MGI Pharma, Inc.
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