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Decitabine Receives US Orphan Drug Designation for AML

Decitabine Receives US Orphan Drug Designation for AML

MGI Pharma, Inc, recently announced that the US Food and Drug Administration (FDA) has granted decitabine (Dacogen) orphan designation for the indication of acute myeloid leukemia (AML). Decitabine was approved by the FDA earlier this year 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 United States, and may provide 7 years of market exclusivity following FDA approval. Previously designated as an orphan drug in the for the MDS indication, decitabine is a hypomethylating agent that is believed to exert its antineoplastic effects by incorporation into DNA and inhibition of the enzyme DNA methyltransferase.

DVD Series on Prostate Cancer Management Available

Prostate Oncology Specialists, a California-based medical group whose focus is prostate cancer prevention and management, recently released an informative three-part DVD series about the disease for patients. The three titles—"A New Perspective: Look Before You Leap," "Systemic Treatments for Prostate Cancer," and "Testosterone Independent Prostate Cancer"—offer a good introduction to prostate cancer diagnosis and the various degrees of aggressiveness of the disease in clear, easy-to-understand language. The DVD lectures are delivered by Dr. Mark Scholz, medical director of Prostate Oncology Specialists, and Dr. Richard Lam, director of clinical research at the facility in Marina del Rey, Calif. Retail price for each DVD is $30. For more information, contact (310) 827-7707, or visit www.prostateoncology.com.

 
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