Skip to Content


Treatment for Myelodysplastic Disease

Dacogen (Decitabine) Injection Complete Response Accepted for Review By U.S. FDA

Dacogen injection is a product candidate that belongs to a class of drugs called hypomethylating agents that is currently being evaluated in a broad clinical development program in patients with MDS, acute myeloid leukemia (AML), chronic myelogenous leukemia (CML), and solid tumors. Dacogen injection is not approved for marketing in the U.S. or by other regulatory agencies in their respective countries; therefore, safety and efficacy have not yet been established in any patient population. The Dacogen injection New Drug Application (NDA) is under review by the FDA for the MDS indication. A phase 3 EORTC-sponsored trial is currently ongoing in Europe to evaluate Dacogen injection in patients with MDS. MGI PHARMA is conducting a pivotal program to evaluate Dacogen injection in patients with AML. Additional clinical studies are also underway in patients with MDS to evaluate alternative dosing regimens for Dacogen injection.

Posted: December 2005

Related Articles

Dacogen (decitabine) FDA Approval History

More News Resources

Subscribe to our Newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of in your inbox.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.