Midostaurin is a multiple kinase inhibitor, which interferes with cellular signal transduction pathways. While the drug exhibits efficacy against a number of kinases, its efficacy against FLT3 is of particular relevance to AML. Patients with FLT3-mutated AML represent a key population subtype, and mutations in FLT3, specifically the FLT3- internal tandem duplication (ITD) mutation, can lead to poorer disease prognosis that in patients with wild-type FLT3.
Midostaurin is the most advanced candidate to become the first targeted therapy to be approved for the treatment of fms-like tyrosine kinase-3 (FLT3) mutated acute myeloid leukemia (AML). Midostaurin is now being developed as an adjunctive therapy. Phase II data showed that midostaurin therapy led to hematological and blast responses in patients, with higher rates achieved in patients with FLT3-mutated AML. This study provided the rationale for Phase III development. If approved, Novartis’s experience bringing targeted therapies to the oncology market will prove useful in improving the commercial prospects for midostaurin.
7 Figure 1: Midostaurin – SWOT analysis for AML
8 Figure 2: Datamonitor Healthcare’s drug assessment summary for midostaurin in AML
8 Figure 3: Datamonitor Healthcare’s drug assessment summary for midostaurin in AML
LIST OF TABLES
4 Table 1: Midostaurin drug profile for acute myeloid leukemia
5 Table 2: Ongoing clinical trial development for midostaurin in AML
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