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Midostaurin
Source: Acute Myeloid Leukemia Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: March 14, 2025 · Captured 2026-09-09.
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Evidence (midostaurin):
A multicenter, randomized, phase III trial (NCT00651261) included patients with FLT3-altered AML. Patients received either the FLT3/multikinase inhibitor, midostaurin, or placebo in addition to cytarabine and daunorubicin induction chemotherapy. The addition of midostaurin led to improved survival (median, 75 vs. 26 months; HR for death, 0.78; one-sided P = .009).[8]
Source links and citations
A multicenter, randomized, phase III trial (NCT00651261) included patients with FLT3-altered AML. Patients received either the FLT3/multikinase inhibitor, midostaurin, or placebo in addition to cytarabine and daunorubicin induction chemotherapy. The addition of midostaurin led to improved survival (median, 75 vs. 26 months; HR for death, 0.78; one-sided P = .009).[8]
The event-free survival (defined as the time from randomization to relapse, death from any cause, or failure to achieve protocol-specified CR) was improved for patients in the midostaurin arm (HR for event or death, 0.78; one-sided P = .002), and the survival benefit was consistent across all FLT3 variant subtypes. The rates of CR (59% vs. 54%) and time to neutrophil count recovery were similar between the two arms.[8][Level of evidence A1]
Source links and citations
The U.S. Food and Drug Administration (FDA) approved midostaurin in combination with induction therapy for patients with AML and any FLT3 variant.
Studies cited in this source section
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Preserved source evidence · Not medical advice