Table 1.
Recent approved drugs for AML with indications.7
| Drug | Date of approval | Indication |
|---|---|---|
| Midostaurin (Rydapt) Novartis |
28 April 2017 | Treatment of adult patients with newly diagnosed AML who are FLT3+* in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation |
| Enasidenib (Idhifa) Celgene |
1 August 2017 | Treatment of adult patients with relapsed or refractory AML with an isocitrate dehydrogenase-2 (IDH2) mutation* |
| CPX-351 (Vyxeos) Jazz Pharmaceuticals |
3 August 2017 | Treatment of adults with newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia related changes (AML-MRC) |
| Gemtuzumab ozogamicin (Mylotarg) Pfizer |
1 September 2017 | Treatment of adults with newly diagnosed CD33-ositive AML and for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. May be used in combination with daunorubicin and cytarabine for adults with newly diagnosed AML. |
| Ivosidenib (Tibsovo) Agios |
20 July 2018 | Adult patients with relapsed or refractory AL with a susceptible IDH1 mutation* |
| Glasdegib (Daurismo) Pfizer |
21 November 2018 | In combination with low-dose cytarabine for the treatment of newly diagnosed AML in adults who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. |
| Venetoclax (Venclexta) Abbvie/Genetech |
21 November 2018 | In combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed AML in adults who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. |
| Gilteritinib (Xospata) Astellas Pharma |
28 November 2018 | Treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation* |
*
Mutational analysis detected by an FDA approved test.
AML, acute myeloid leukemia.