Table 3. Recent FDA approvals for... | American Society of Hematology

Table 3.

Recent FDA approvals for relapsed/refractory AML

Drug/regimen	FDA approval indication⁵⁶	Age in study, y	N	ORR, %	CR, %	CRi, %	30-d early death, %	Survival, median no. of mo
Mylotarg⁵⁹/GO	RR adults or pediatric patients ≥2 y with CD33⁺ AML with IC	50-70	135	81	70	11 (CRp)	3.8	27.5
Tibsovo⁴⁴/ivosidenib	RR IDH1^MUT	18-89	258	34	22	12	7	8.8
Idhifa⁶²/enasidenib mesylate	RR IDH2^MUT	19-100	214	29	20	9	5	8.8
Xospata²⁷/gilteritinib fumarate	RR FLT3^MUT	19-85	247	34	21	13 (CRh)	2	9.3

Drug/regimen	FDA approval indication⁵⁶	Age in study, y	N	ORR, %	CR, %	CRi, %	30-d early death, %	Survival, median no. of mo
Mylotarg⁵⁹/GO	RR adults or pediatric patients ≥2 y with CD33⁺ AML with IC	50-70	135	81	70	11 (CRp)	3.8	27.5
Tibsovo⁴⁴/ivosidenib	RR IDH1^MUT	18-89	258	34	22	12	7	8.8
Idhifa⁶²/enasidenib mesylate	RR IDH2^MUT	19-100	214	29	20	9	5	8.8
Xospata²⁷/gilteritinib fumarate	RR FLT3^MUT	19-85	247	34	21	13 (CRh)	2	9.3

RR, relapsed/refractory. See Table 2 for expansion of other abbreviations.