Midostaurin FDA and EMA approved indications
| . | Indications . |
|---|---|
| FDA1 | Midostaurin is a kinase inhibitor indicated for the treatment of (1) adult patients with newly diagnosed AML that is FLT3-mutation positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation, and (2) adult patients with ASM, SM-AHN, or MCL. Limitations of use: midostaurin is not indicated as a single-agent induction therapy for the treatment of patients with AML. |
| EMA2 | Midostaurin is indicated (1) in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy and for patients in complete response followed by midostaurin single-agent maintenance therapy, for adult patients with newly diagnosed AML who are FLT3-mutation positive; and (2) as monotherapy for the treatment of adult patients with ASM, SM-AHN, MCL. |
| . | Indications . |
|---|---|
| FDA1 | Midostaurin is a kinase inhibitor indicated for the treatment of (1) adult patients with newly diagnosed AML that is FLT3-mutation positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation, and (2) adult patients with ASM, SM-AHN, or MCL. Limitations of use: midostaurin is not indicated as a single-agent induction therapy for the treatment of patients with AML. |
| EMA2 | Midostaurin is indicated (1) in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy and for patients in complete response followed by midostaurin single-agent maintenance therapy, for adult patients with newly diagnosed AML who are FLT3-mutation positive; and (2) as monotherapy for the treatment of adult patients with ASM, SM-AHN, MCL. |
ASM, aggressive systemic mastocytosis; EMA, European Medicines Agency; FDA, US Food and Drug Administration; MCL, mast cell leukemia; SM-AHN, systemic mastocytosis with associated hematological neoplasm.