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Table 1 Approval status of hypomethylating agents (HMAs)

From: The double-edged sword of (re)expression of genes by hypomethylating agents: from viral mimicry to exploitation as priming agents for targeted immune checkpoint modulation

  AZA DAC
FDA EMA FDA EMA
MDS
 - low-risk Yesa (19.05.2004) No Yesc(02.05.2006) No
 - high risk Yesa (19.05.2004) Yesb (17.12.2008) Yesc (02.05.2006) No
CMML-FAB
 - CMML-MD Yes (19.05.2004) Yesb (17.12.2008) Yesc(02.05.2006) No
 - CMML-MP Yes (19.05.2004) No Yesc (02.05.2006) No
CMML-WHO
 - CMML-I Yes (19.05.2004) No Yesc(02.05.2006) No
 - CMML-II Yes (19.05.2004) Yesb (17.12.2008) Yesc (02.05.2006) No
AML
 - 20–30% BM blasts Yes (19.05.2004) Yesb,d (17.12.2008) Yesd,e (02.05.2006) Yesd,e (20.09.2012)
  > 30% BM blasts No Yes (30.10.2015) No Yesd,e (20.09.2012)
  1. aif accompanied by neutropenia or thrombocytopenia requiring transfusions
  2. bnot eligible to allo-SCT
  3. cincluding previously treated and untreated de novo and secondary MDS of all FAB-subtypes
  4. dAML with 20–30% BM blasts and multilineage dysplasia, formerly RAEB-t
  5. e > 65a, not eligible for intensive CTX, de novo or secondary, newly diagnosed AML