Pharma Focus America

Invivoscribe's FLT3 Mutation Assay Granted FDA Approval for Targeting VANFLYTA Treatment in FLT3-ITD Positive AML Patients

Monday, July 24, 2023

Invivoscribe has announced that the LeukoStrat® CDx FLT3 Mutation Assay has received approval from the U.S. Food and Drug Administration (FDA) for assisting in the selection of newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) patients who may be eligible for treatment with Daiichi Sankyo's VANFLYTA® (quizartinib).

The LeukoStrat CDx FLT3 Mutation Assay serves to identify AML patients with FLT3-ITD mutations who can benefit from the newly approved targeted therapy.

Intended Use in the U.S.:

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene within genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).

It is intended to aid in the assessment of AML patients being considered for RYDAPT® (midostaurin) treatment.

Additionally, the assay is used as an aid in assessing patients with AML for whom XOSPATA® (gilteritinib) treatment is being considered.

Furthermore, it is utilized to assess patients with FLT3-ITD+ AML for whom VANFLYTA® (quizartinib) treatment is being considered.

The test is conducted using the 3500xL Dx Genetic Analyzer.

Jeffrey Miller, Invivoscribe's CSO, CEO, and founder, expressed his enthusiasm, stating, "FDA approval of the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic to VANFLYTA is a significant milestone for patients with newly diagnosed FLT3-ITD positive AML. Timely and accurate testing for FLT3-ITD mutations in newly diagnosed patients is critical to identify those who may be eligible for treatment with VANFLYTA, and we are happy to collaborate with Daiichi Sankyo to help bring this important new therapy to patients."

AML is a type of blood cancer affecting the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. It has the lowest 5-year survival rate (31.7%) among people diagnosed with leukemia. About 25% of AML patients have a FLT3-ITD mutation, which contributes to the growth and survival of cancer cells and is associated with a poor prognosis.

Prior to this, the LeukoStrat CDx FLT3 Mutation Assay had already obtained approval from the Japan Pharmaceuticals and Medical Devices Agency (PMDA) to be used as a companion diagnostic for selecting FLT3-ITD positive AML patients eligible for VANFLYTA in Japan.

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