Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells.
The new outpatient dosing option provides physicians and patients with the flexibility of a dosing regimen with a reduced infusion time. Dacogen is the only hypomethylating agent approved for a five-day dosing regimen. The new regimen will be administered at a dose of 20 mg/m2 continuous intravenous (IV) infusion over one hour repeated daily for five days per cycle. The cycle is repeated every four weeks.
The previously approved Dacogen three-day regimen is administered in an in-patient setting at a dose of 15 mg/m2 continuous IV infusion over three hours repeated every eight hours for three days per cycle and repeated every six weeks.
Three open-label, single-arm, multicenter studies were conducted to evaluate the safety and efficacy of Dacogen in MDS patients with any of the French-American-British (FAB) subtypes. In one study, 99 patients with International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2, or high-risk prognostic scores received Dacogen by IV infusion at a dose of 20 mg/m2 continuous IV infusion over one hour repeated daily for five days per cycle. The cycle is repeated every four weeks.
If myelosuppression is present, subsequent treatment cycles of Dacogen should be delayed until there is a hematologic recovery.
The Dacogen study results, based on International Working Group 2000 Response Criteria, showed that patients experienced an overall response rate (ORR) of 16 percent (complete remission [CR] of 15 percent and a partial response [PR] of 1 percent). In addition, the median time to (CR+PR) response was 162 days and the median duration of (CR+PR) response was 443 days. These results were consistent with the results of the Phase III controlled trial. The highest incidences of Grade 3 or Grade 4 adverse events in the Dacogen arm were neutropenia (37%), thrombocytopenia (24%), and anemia (22%).
"The approval of Dacogen offers doctors and patients the flexibility of choosing the most appropriate dosing regimen for an individual patient," said Steven C. Sembler, Senior Vice President of Commercial U.S. Pharmaceuticals at Eisai Inc. "This important milestone demonstrates our commitment to furthering Eisai's human health care mission of increasing benefits for patients and their families."
SOURCE Eisai Inc.