FDA approves SuperGen, MGI Pharma's Dacogen for injection to treat patients with myelodysplastic syndromes

By E. Janene Geiss

Philadelphia, May 3 - MGI Pharma, Inc. and SuperGen, Inc. announced Wednesday that the Food and Drug Administration has approved Dacogen (decitabine) for injection.

Dacogen is indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation and chronic myelomonocytic leukemia), according to a company news release.

MGI said it plans to make Dacogen commercially available during the second quarter of 2006.

Results from a phase 3 clinical trial demonstrated an overall response rate of 21% in Dacogen-treated patients considered evaluable for response, defined as those patients with pathologically confirmed disease at baseline who received at least two cycles of treatment, compared to 0% in the supportive care arm.

All patients who responded to Dacogen treatment became or remained transfusion independent during the time of the response, officials said.

The most commonly occurring adverse reactions with Dacogen include neutropenia, thrombocytopenia, anemia, pyrexia, fatigue, nausea, cough, petechiae, constipation and diarrhea.

MGI said it is conducting a phase 3 pivotal trial to evaluate Dacogen in patients with acute leukemia. Additional phase 2 studies are also underway to evaluate alternative dosing regimens for Dacogen in patients with myelodysplastic syndromes and in patients with acute leukemia and chronic myelogenous leukemia.

Myelodysplastic syndromes 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.

Dacogen is a hypomethylating agent that is believed to exert its antineoplastic effects by incorporation into DNA and inhibition of an enzyme called DNA methyltransferase.

SuperGen is a Dublin, Calif., pharmaceutical company that discovers, acquires and develops therapies for solid tumors, hematological malignancies and blood disorders.

MGI is a Minneapolis oncology- and acute care-focused biopharmaceutical company that acquires, researches, develops and commercializes proprietary products.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.