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Molecular Profile | FLT3 exon 15 ins |
Therapy | Gilteritinib |
Indication/Tumor Type | acute myeloid leukemia |
Response Type | sensitive |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
FLT3 exon 15 ins | acute myeloid leukemia | sensitive | Gilteritinib | Guideline | Actionable | Xospata (gilteritinib) is included in the guidelines for patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (FLT3-ITD) mutation (NCCN.org). | detail... |
FLT3 exon 15 ins | acute myeloid leukemia | sensitive | Gilteritinib | Guideline | Actionable | Xospata (gilteritinib) is included in the guidelines for patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (FLT3-ITD) mutation (PMID: 32171751; ESMO.org). | 32171751 detail... |
FLT3 exon 15 ins | acute myeloid leukemia | sensitive | Gilteritinib | FDA approved - On Companion Diagnostic | Actionable | In a Phase III trial (ADMIRAL) that supported FDA approval, Xospata (gilteritinib) improved median overall survival (9.3 vs 5.6 mo, HR. 0.64, p<0.001), median event-free survival (2.8 vs 0.7 mo, HR 0.79), and rate of complete remission with full or partial hematologic recovery (34.0% vs 15.3%) compared to chemotherapy in patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (ITD; exon 14/15 insertion), D835, or I836 mutation (PMID: 31665578; NCT02421939). | detail... 31665578 detail... |
PubMed Id | Reference Title | Details |
---|---|---|
NCCN.org | Full reference... | |
ESMO Clinical Practice Guidelines | Full reference... | |
Full reference... | ||
Xospata (gilteritinib) FDA Drug Label | Full reference... | |
(32171751) | Acute myeloid leukaemia in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. | Full reference... |
(31665578) | Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML. | Full reference... |