Table 1.
Approval status of hypomethylating agents (HMAs)
| 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) |
aif accompanied by neutropenia or thrombocytopenia requiring transfusions
bnot eligible to allo-SCT
cincluding previously treated and untreated de novo and secondary MDS of all FAB-subtypes
dAML with 20–30% BM blasts and multilineage dysplasia, formerly RAEB-t
e > 65a, not eligible for intensive CTX, de novo or secondary, newly diagnosed AML