Invivoscribe announced Monday that it has filed a supplemental Pre-Market Approval (sPMA) submission with the U.S. Food and Drug Administration (FDA) for its LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's investigational drug quizartinib.
The investigational drug is used in the treatment of newly diagnosed acute myeloid leukemia (AML) patients with the FLT3-ITD mutation.
The filing supports Daiichi Sankyo's new drug application (NDA) for quizartinib for the treatment of adult patients with newly diagnosed FLT3-ITD positive AML. The application has been granted Priority Review status by the FDA.
The LeukoStrat CDx FLT3 Mutation Assay is used to identify newly diagnosed AML patients with the FLT3-ITD mutation. It has already been approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for use as a companion diagnostic with quizartinib.
FLT3 mutations are a significant driver mutation in AML, with the internal tandem duplication (ITD) mutation occurring in about 25% of newly diagnosed adults with AML, and the tyrosine kinase domain (TKD) mutation occurring in about 5%.
LeukoStrat CDx FLT3 Mutation Assay kits are currently distributed in Japan, the U.S., Europe, and China.