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FDA approval given for injectable form of decitabine

Nov 23, 2021

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.

  1. BusinessToday.In. Zydus Cadila receives USFDA approval to market generic cancer drug in US. Accessed November 22, 2021. Published November 20, 2021.
  2. Saba HI. Decitabine in the treatment of myelodysplastic syndromes. Ther Clin Risk Manag. 2007;3(5):807-817.