Recent FDA approvals in newly diagnosed AML
| Drug/regimen . | FDA approval indication56 . | Age in study, y . | N . | ORR, % . | CR, % . | CRi, % . | 30-d early death, % . | Survival . |
|---|---|---|---|---|---|---|---|---|
| Rydapt57 /midostaurin + IC | FLT3MUT AML | 18-59 | 360 | — | 59 | N/A | 4.5 | 51.4% at 4 y |
| Vyxeos58 /CPX-351 liposomal daunorubicin HCl and cytarabine | tAML, AML MRC | 60-75 | 153 | 47 | 37 | 10 | 5.9 | Median, 9.6 mo |
| Mylotarg59 /GO | Newly diagnosed adults with CD33+ AML with IC | 50-70 | 135 | 81 | 70 | 11 (CRp) | 3.8 | Median, 27.5 mo |
| Daurismo6 /glasdegib + LDAC | >75 yo or unfit for IC | 63-92 | 88 | 27 | 17 | 10 | N/A | Median, 8.8 mo |
| Venclexta60 /venetoclax + HMA | New AML ≥75 y or unfit* | 65-86 | 145 | 67 | 37 | 30 | 3 | Median, 17.5 mo |
| Venclexta8 /venetoclax + LDAC | New AML ≥75 y or unfit* | 63-90 | 82 | 54 | 26 | 28 | 6 | Median, 10.1 mo |
| Tibsovo61 /ivosidenib | New AML ≥75 y or unfit* with IDH1MUT | 64-87 | 34 | 42 | 30 | 12 (CRh) | N/A | N/A |
| Drug/regimen . | FDA approval indication56 . | Age in study, y . | N . | ORR, % . | CR, % . | CRi, % . | 30-d early death, % . | Survival . |
|---|---|---|---|---|---|---|---|---|
| Rydapt57 /midostaurin + IC | FLT3MUT AML | 18-59 | 360 | — | 59 | N/A | 4.5 | 51.4% at 4 y |
| Vyxeos58 /CPX-351 liposomal daunorubicin HCl and cytarabine | tAML, AML MRC | 60-75 | 153 | 47 | 37 | 10 | 5.9 | Median, 9.6 mo |
| Mylotarg59 /GO | Newly diagnosed adults with CD33+ AML with IC | 50-70 | 135 | 81 | 70 | 11 (CRp) | 3.8 | Median, 27.5 mo |
| Daurismo6 /glasdegib + LDAC | >75 yo or unfit for IC | 63-92 | 88 | 27 | 17 | 10 | N/A | Median, 8.8 mo |
| Venclexta60 /venetoclax + HMA | New AML ≥75 y or unfit* | 65-86 | 145 | 67 | 37 | 30 | 3 | Median, 17.5 mo |
| Venclexta8 /venetoclax + LDAC | New AML ≥75 y or unfit* | 63-90 | 82 | 54 | 26 | 28 | 6 | Median, 10.1 mo |
| Tibsovo61 /ivosidenib | New AML ≥75 y or unfit* with IDH1MUT | 64-87 | 34 | 42 | 30 | 12 (CRh) | N/A | N/A |
—, not available; AML MRC, AML with myelodysplasia-related changes; CR, complete remission; CRh, CR with hematologic recovery; CRi, CR with incomplete hematologic recovery; CRp, CR with platelet recovery; GO, gemtuzumab ozogomycin; HMA, hypomethylating agent; IC, intensive chemotherapy; LDAC, low-dose cytarabine; N/A, not available; ORR, overall response rate; t-AML, therapy-related AML; yo, years old.
Adult patients with newly diagnosed AML who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.