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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