In Table 2 on page 450 of the 27 February 2018 issue, the entry in the second column of the first row incorrectly stated that midostaurin is not indicated by the US Food and Drug Administration (FDA) for treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). It should have stated that midostaurin is indicated by the FDA for treatment of adults with those conditions. The corrected Table 2 is shown below. The error has been corrected in the published article.
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.
