FDA approves both Xospata and companion diagnostic LeukoStrat CDx FLT3 Mutation Assay for AML.- Astellas + Invivoscribe.

The FDA has approved both the LeukoStrat CDx FLT3 Mutation Assay, from Invivoscribe, and Xospata (gilteritinib fumarate), from Astellas, for treatment of FLT3 positive refractory/relapse acute myeloid leukemia (AML) patients in the US. Invivoscribe developed the LeukoStrat CDx FLT3 Mutation Assay in partnership with Astellas as the companion diagnostic to predict patient responses to Astellas Pharma's AML drug Xospata (gilteritinib fumarate).

This approval complements Invivoscribe’s prior regulatory approvals of this LeukoStrat CDx FLT3 Mutation Assay as the companion diagnostic for Rydapt (midostaurin) for Novartis (United States and Europe), and Xospata (gilteritinib fumarate) for Astellas (Japan). This CDx was also recently submitted to the PMDA in Japan and the US FDA as the CDx for predicting response to the Daiichi Sankyo drug, quizartinib hydrochloride.

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based, in vitro diagnostic test designed to detect internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia. This globally standardized test includes software that interprets data, generates mutant/wildtype signal ratios for ITD and TKD mutations, and predicts response to both gilteritinib fumarate and midostaurin. This extensively validated assay helps standardize the detection of genetic mutations in the FLT3 gene as one of the most important driver mutations in Acute Myeloid Leukemia (AML).