05.03.06

Hypomethylating Drug Approved by FDA for Treatment of MDS

Posted in news links at 12:34 pm by admin

The U.S. Food and Drug Administration has approved Dacogen for Injection, a drug developed by MGI Pharma, Inc. and SuperGen, Inc. for the treatment of myelodysplastic syndromes (MDS).

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 MDS at baseline who received at least 2 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.

Dacogen for Injection works by inhibition of the enzyme DNA methyltransferase, which in turn affects the methylation of DNA that affects genes involved in cellular differentation and proliferation.

Dacogen-induced hypomethylation in neoplastic cells may restore normal function to genes that are critical for the control of cellular differentiation and proliferation. In rapidly dividing cells, the cytotoxicity of Dacogen may also be attributed to the formation of covalent adducts between DNA methyltransferase and decitabine incorporated into DNA.

The drug will be commercially available by the end of June. Link