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On November 20, 2021, the U.S. Food and Drug Administration (FDA) announced that it was giving approval for a generic, injectable form of decitabine to be marketed for patients with myelodysplastic syndromes along with specific leukemias and lymphomas in the USA. The drug will be marketed at a strength of 50 mg/vial in a one-dose injection vial.1
Decitabine is believed to have a dual mechanism of action depending on the dose used. At high doses decitabine is cytotoxic and at low doses it acts as a hypomethylating agent (HMA) by inhibiting DNA methyltransferase.2
Generic forms of HMAs should enable more patients to have access these medicines. Another method to improve patient access is to change the route of administration. Oral HMAs could also benefit patients by reducing the number of clinic visits necessary for treatment. For more about oral HMAs, check out this video in which Guillermo Garcia-Manero discusses how oral HMAs changed the management of MDS.
The impact of CD33 and ABCB1 SNPs on clinical outcomes in AML: A retrospective analysis of a phase II decitabine and gemtuzumab ozogamicin study in AML and high-risk MDS
Recently, a retrospective analysis evaluated the impact of SNPs of CD33 and...
Oral formulations of cedazuridine and decitabine for patients with MDS
Hypomethylating agents (HMAs), such as azacitidine and decitabine, are the main treatment options for myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).
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