FDA/EMA approvals for R/R AML
| Agent . | FDA/EMA approval . | Age in study, y . | N . | ORR, % . | CR, % . | CRi, % . | Median survival, mo . | Reference . |
|---|---|---|---|---|---|---|---|---|
| Ivosidenib | IDH1-mutated R/R AML/not authorized by EMA | 18-89 | 258 | 42 | 22 | 9 | 8.8 | 65 |
| Olutasidenib | IDH1-mutated R/R AML/not authorized by EMA | 32-87 | 153 | 48 | 32 | 10 | 11.6 | 66 |
| Enasidenib | IDH2-mutated R/R AML/not authorized by EMA | 19-100 | 109 | 40 | 19 | 7 | 9.3 | 64 |
| Gemtuzumab ozogamicin | CD33+ R/R AML as monotherapy/not authorized by EMA | 20-87 | 277 | 26 | 13 | 13 (CRp) | 4.9 | 97 |
| Gilteritinib | FLT3-mutated R/R AML | 20-84 | 247 | 54 | 21 | 26 | 9.3 | 27 |
| Agent . | FDA/EMA approval . | Age in study, y . | N . | ORR, % . | CR, % . | CRi, % . | Median survival, mo . | Reference . |
|---|---|---|---|---|---|---|---|---|
| Ivosidenib | IDH1-mutated R/R AML/not authorized by EMA | 18-89 | 258 | 42 | 22 | 9 | 8.8 | 65 |
| Olutasidenib | IDH1-mutated R/R AML/not authorized by EMA | 32-87 | 153 | 48 | 32 | 10 | 11.6 | 66 |
| Enasidenib | IDH2-mutated R/R AML/not authorized by EMA | 19-100 | 109 | 40 | 19 | 7 | 9.3 | 64 |
| Gemtuzumab ozogamicin | CD33+ R/R AML as monotherapy/not authorized by EMA | 20-87 | 277 | 26 | 13 | 13 (CRp) | 4.9 | 97 |
| Gilteritinib | FLT3-mutated R/R AML | 20-84 | 247 | 54 | 21 | 26 | 9.3 | 27 |
CRp, CR with incomplete platelet recovery; IC, intensive chemotherapy; N, number of patients in the study.