Dacogen™ Approved for Myelodysplastic Syndromes
The United States Food and Drug Administration (FDA) has approved the agent Dacogen™ (decitabine) for the treatment of patients with myelodysplastic syndromes (MDS).
Myelodysplastic syndromes are a group of blood (hematologic) disorders that are diagnosed in 10,000 to 20,000 individuals annually in the U.S. MDS occurs when immature blood cells do not mature properly and are never able to perform their intended function. They instead crowd out normal blood cells in the bone marrow, often inhibiting other cells from performing their intended functions.
MDS can also develop into an aggressive form of leukemia, acute myelogenous leukemia (AML). Preventing or delaying the development of MDS into AML is an important consideration since long-term survival for AML is not favorable.
The different classifications of MDS range from low-risk to high-risk. Low-risk patients often have less aggressive disease that may be managed with blood transfusions (referred to as transfusion-dependent) or agents that stimulate red blood cell growth, such as Aranesp®. High-risk patients may need more aggressive management of their disease. Since blood transfusions are time consuming, require medical resources, increase medical costs, and are associated with the potential of infection, pain, and other reactions, reducing or preventing the need for the transfusions in patients with MDS is a major consideration.
The FDA approval for Dacogen was prompted by results of clinical trials demonstrating that it effectively improved outcomes in patients with MDS when compared to supportive care. Overall, Dacogen provided anticancer responses in approximately 17%-26% of patients in these trials—demonstrating a significant improvement over supportive care measures. These responses reduced the need for blood transfusions in a significant portion of patients.
Dacogen continues to be evaluated in clinical studies to provide further data on its potential in the treatment of MDS.
Patients diagnosed with MDS may wish to speak with their physician regarding their individual risks and benefits of treatment with Dacogen.
Reference: MGI Pharma. U.S. FDA Approves Dacogen(TM) (Decitabine) for Injection; Dacogen(TM) Approved for Patients with all FAB Classifications of MDS; Commercial Launch Planned For Late May. Available at: http://investors.mgipharma.com/phoenix.zhtml?c=73842&p=irol-newsArticle&ID=851140&highlight=. Accessed May 2006.
Myelodysplastic syndromes are a group of blood (hematologic) disorders that are diagnosed in 10,000 to 20,000 individuals annually in the U.S. MDS occurs when immature blood cells do not mature properly and are never able to perform their intended function. They instead crowd out normal blood cells in the bone marrow, often inhibiting other cells from performing their intended functions.
MDS can also develop into an aggressive form of leukemia, acute myelogenous leukemia (AML). Preventing or delaying the development of MDS into AML is an important consideration since long-term survival for AML is not favorable.
The different classifications of MDS range from low-risk to high-risk. Low-risk patients often have less aggressive disease that may be managed with blood transfusions (referred to as transfusion-dependent) or agents that stimulate red blood cell growth, such as Aranesp®. High-risk patients may need more aggressive management of their disease. Since blood transfusions are time consuming, require medical resources, increase medical costs, and are associated with the potential of infection, pain, and other reactions, reducing or preventing the need for the transfusions in patients with MDS is a major consideration.
The FDA approval for Dacogen was prompted by results of clinical trials demonstrating that it effectively improved outcomes in patients with MDS when compared to supportive care. Overall, Dacogen provided anticancer responses in approximately 17%-26% of patients in these trials—demonstrating a significant improvement over supportive care measures. These responses reduced the need for blood transfusions in a significant portion of patients.
Dacogen continues to be evaluated in clinical studies to provide further data on its potential in the treatment of MDS.
Patients diagnosed with MDS may wish to speak with their physician regarding their individual risks and benefits of treatment with Dacogen.
Reference: MGI Pharma. U.S. FDA Approves Dacogen(TM) (Decitabine) for Injection; Dacogen(TM) Approved for Patients with all FAB Classifications of MDS; Commercial Launch Planned For Late May. Available at: http://investors.mgipharma.com/phoenix.zhtml?c=73842&p=irol-newsArticle&ID=851140&highlight=. Accessed May 2006.
posted by TM at 9:12 AM
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