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TEST:
LeukoStrat® CDx FLT3 Mutation Assay

Type:
FDA Approved
Related tests:
Evidence Level:
Sensitive: A1 - Approval

[FLT3-ITD mutation-Acute Myelogenous Leukemia-quizartinib]

Source:
Published date:
07/20/2023
Excerpt:
VANFLYTA is a kinase inhibitor indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.
Secondary therapy:
cytarabine; Chemotherapy
Evidence Level:
Sensitive: A1 - Approval

[FLT3 mutation-Acute Myelogenous Leukemia-gilteritinib]

Published date:
10/24/2019
Excerpt:
Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.
Evidence Level:
Sensitive: A1 - Approval

[FLT3 mutation-Acute Myelogenous Leukemia-gilteritinib]

Source:
Published date:
11/28/2018
Excerpt:
XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
Evidence Level:
Sensitive: A1 - Approval

[FLT3 mutation-Acute Myelogenous Leukemia-midostaurin]

Source:
Published date:
04/28/2017
Excerpt:
RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with:...Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
Secondary therapy:
cytarabine + daunorubicin
Evidence Level:
Sensitive: B - Late Trials

[FLT3-ITD mutation-Acute Myelogenous Leukemia-gilteritinib]

Title:
Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML
Published date:
10/31/2019
Excerpt:
A consistent pattern of longer survival with gilteritinib than with chemotherapy was noted across multiple subgroups, including the high-intensity and low-intensity chemotherapy cohorts (Figure 2B) and the high FLT3 ITD allelic ratio subgroup (median overall survival, 7.1 vs. 4.3 months; hazard ratio for death, 0.49; 95% CI, 0.34 to 0.71)....gilteritinib therapy led to higher percentages of patients with response and longer survival than salvage chemotherapy among patients with relapsed or refractory FLT3-mutated AML.
Secondary therapy:
Chemotherapy
DOI:
10.1056/NEJMoa1902688
Trial ID:
Evidence Level:
Sensitive: B - Late Trials

[FLT3-TKD mutation-Acute Myelogenous Leukemia-midostaurin]

Title:
Midostaurin plus Chemotherapy for Acute Myeloid Leukemia with a FLT3 Mutation
Excerpt:
Patients were randomly assigned to receive standard chemotherapy (induction therapy with daunorubicin and cytarabine...The FLT3 subtype was ITD (high) in 214 patients, ITD (low) in 341 patients, and TKD in 162 patients. The treatment groups were well balanced with respect to age, race, FLT3 subtype, cytogenetic risk, and blood counts but not with respect to sex (51.7% in the midostaurin group vs. 59.4% in the placebo group were women, P=0.04). Overall survival was significantly longer in the midostaurin group than in the placebo group (hazard ratio for death, 0.78; one-sided P=0.009), as was event-free survival (hazard ratio for event or death, 0.78; one-sided P=0.002). In both the primary analysis and an analysis in which data for patients who underwent transplantation were censored, the benefit of midostaurin was consistent across all FLT3 subtypes. The rate of severe adverse events was similar in the two groups.
Secondary therapy:
cytarabine + daunorubicin
DOI:
10.1056/NEJMoa1614359
Trial ID:
Evidence Level:
Sensitive: B - Late Trials

[FLT3-ITD mutation-Acute Myelogenous Leukemia-midostaurin]

Title:
Midostaurin plus Chemotherapy for Acute Myeloid Leukemia with a FLT3 Mutation
Excerpt:
The FLT3 subtype was ITD (high) in 214 patients, ITD (low) in 341 patients, and TKD in 162 patients. The treatment groups were well balanced with respect to age, race, FLT3 subtype, cytogenetic risk, and blood counts but not with respect to sex (51.7% in the midostaurin group vs. 59.4% in the placebo group were women, P=0.04). Overall survival was significantly longer in the midostaurin group than in the placebo group (hazard ratio for death, 0.78; one-sided P=0.009), as was event-free survival (hazard ratio for event or death, 0.78; one-sided P=0.002). In both the primary analysis and an analysis in which data for patients who underwent transplantation were censored, the benefit of midostaurin was consistent across all FLT3 subtypes. The rate of severe adverse events was similar in the two groups.
Secondary therapy:
cytarabine + daunorubicin
DOI:
10.1056/NEJMoa1614359
Trial ID: