Eisai Will Initiate First Head-to-Head Study Comparing Dacogen(R) (decitabine for injection) and Vidaza(R) (azacitidine) in Patients with Myelodysplastic Syndromes
Randomized Comparator Study to Evaluate Efficacy of Commercially Available Hypomethylating Agents
“Previous to the introduction of the hypomethylating agents, supportive care was the only treatment option for patients living with MDS,” said Dr.
This randomized, multi-center, open-label study will be conducted among 228 adult patients with intermediate-1, intermediate-2 and high-risk MDS. Patients will be randomized on a 1:1 ratio to either Dacogen(R) or Vidaza(R). Each treatment arm will be stratified by IPSS risk group and type of MDS (primary vs. secondary).
The study’s primary objective is to compare the complete response rates, including bone marrow response rates, for Dacogen(R) versus Vidaza(R).
“Findings from this trial could help clarify the fundamental differences between Dacogen and Vidaza and ultimately help clinicians with treatment selection,” said Dr.
Eisai is committed to a clinical development program to optimize the utility of Dacogen(R) for patients with MDS. To advance the understanding of optimal treatment for MDS, hematological malignancies and other cancers, there are currently more than 30 ongoing trials with Dacogen(R) either as a single agent or in combination with other therapies.
Myelodysplastic syndromes, or MDS, are a group of diseases of the bone marrow characterized by the production of poorly functioning and immature blood cells. People with MDS may experience a variety of symptoms and complications, including anemia, bleeding, infection, fatigue and weakness. Those patients with high-risk MDS may experience bone marrow failure, which may lead to death from bleeding and infection. Over time, MDS can progress to acute leukemia, or AML. The Aplastic Anemia and MDS International Foundation currently estimates that up to 30,000 new cases of MDS are diagnosed annually in
Dacogen(R) (decitabine for injection) was approved by the U.S. Food and Drug Administration on
Dacogen(R) may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while using Dacogen(R). Men should be advised not to father a child while receiving treatment with Dacogen(R) and for two months afterwards. The most commonly occurring adverse reactions with Dacogen(R) 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.dacogen.com for full prescribing information.
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