The MDS Beacon™

The United States Food and Drug Administration (FDA) has approved a new dosing schedule for Dacogen (decitabine) for myelodysplastic syndromes (MDS) patients giving them the option of receiving Dacogen  without overnight hospital stays.

Patients on the new regimen receive 20 mg/m² of Dacogen by intravenous infusion over one hour for five consecutive days, every four weeks. The new regimen decreases the infusion time compared to the current dosing schedule.

Under the current dosing schedule, patients receive 15 mg/m² of Dacogen by intravenous infusion for three hours, every eight hours.  This regimen lasts three consecutive days requiring patients to stay at the hospital for two nights. The regimen is repeated every six weeks. 

Research showed that patients receiving Dacogen on the new schedule responded at a rate comparable to the current dose.  Of the 99 MDS patients, 16 percent responded to the outpatient dosing schedule after a median of 162 days.  The median duration of response was 443 days.

Side effects remained similar to the old Dacogen schedule.  Patients experienced low white blood cell count (37 percent), low red blood cell count (22 percent), and low platelet count (24 percent).  Fever, red and itchy skin, and abnormally high blood sugar may also occur.

Dacogen is approved to treat all sub-types of MDS.  The drug removes methyl groups that are bound to the DNA of rapidly dividing mis-shapen and immature blood cells (dysplastic cells) in the bone marrow, which block the regulation of cellular growth.  As a DNA demethylating agent, Dacogen removes these methyl groups and allows the DNA sequences to function normally.

Complete blood counts should be performed while taking Dacogen to monitor response and side effects because treatment is often associated with low white blood cell counts and low platelet counts. 

Please see the Esai’s press release for more information.