Table 1.
The recent FDA-approved agents.
| Newly Diagnosed AML | |||
| Drug/Regimen | FDA Approval Indication | Approval Date | Identifier |
| Rydapt/midostaurin + IC | FLT3 mutated AML | 28 April 2017 | NCT00651261 |
| Mylotarg/GO | Adults or pediatric patients ≥ 1 m with newly diagnosed CD33 positive AML | 1 September 2017 (Reapproval) 16 June 2020 (FDA extended the indication to pediatric patients ≥ 1 month) |
NCT00927498 NCT00372593 |
| Daurismo/glasdegib + LDAC | > 75 y or unfit for IC | 21 November 2018 (accelerated approval) |
NCT01546038 |
| Venclexta/venetoclax + HMA | New AML ≥ 75 y or unfit | 21 November 2018 (accelerated approval) |
NCT02203773 |
| Venclexta/venetoclax + LDAC | New AML ≥ 75 y or unfit | 21 November 2018 (accelerated approval) |
NCT02287233 |
| Tibsovo/ivosidenib | New AML ≥ 75 y or unfit with IDH mutation | 2 May 2019 | NCT02074839 |
| Relapsed/Refractory AML | |||
| Drug/Regimen | FDA Approval Indication | Approval Date | Identifier |
| Mylotarg/GO | Adults or pediatric patients ≥ 2 y with R/R CD33 positive AML | 1 September 2017 (Reapproval) |
- |
| Tibsovo/ivosidenib | R/R IDH1 mutated AML | 20 July 2018 | NCT02074839 |
| Idhifa/enasidenib mesylate | R/R IDH2 mutated AML | 1 August 2017 | NCT01915498 |
| Xospata/gilteritinib fumarate | R/R FLT3 mutated AML | 28 November 2018 | NCT02421939 |
Abbreviation; IC, intensive chemotherapy; GO, Gemtuzumab ozogamicin; HMA, hypomethylating agents; LADC, low dose cytarabine; R/R, relapsed or refractory.