FDA Approves Invivoscribe's CDx for AML Drug Xospata

November 30, 2018
FDA Approves Invivoscribe's CDx for AML Drug Xospata
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Invivoscribe announced it received U.S. Food and Drug Adminsitration (FDA) approval of it LeukoStrat CDx FLT3 Mutation Assay for use in conjunction with the Astellas drug, XOSPATA (gilteritinib fumarate), for treatment of FLT3 positive refractory/relapse acute myeloid leukemia (AML) patients in the U.S.

This approval complements Invivoscribe’s prior regulatory approvals of this LeukoStrat CDx FLT3 Mutation Assay as the companion diagnostic for RYDAPT (midostaurin) for Novartis in the U.S. and Europe. The CDx was also recently submitted to the PMDA in Japan and the FDA as the CDx for predicting response to the Daiichi Sankyo drug, quizartinib hydrochloride.

This approval further establishes the LeukoStrat CDx FLT3 Mutation Assay as the international gold standard for comprehensive FLT3 assessment for critically ill AML patients as this CDx identifies both ITD and TKD mutations (including large internal tandem duplications), is available worldwide, and generates standardized signal ratios for both ITD and TKD mutations.

“Invivoscribe welcomes opportunities to use our Streamlined CDx program to partner with global pharmaceutical companies interested in developing and commercializing companion diagnostics, whether their therapies are targeting hematologic diseases or solid tumors,” said Jeffrey Miller, Invivoscribe’s CSO and CEO in a press release.

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).

The LeukoStrat test is available as a test menu service through the Invivoscribe subsidiaries, LabPMM LLC (San Diego, CA, US), LabPMM GmbH (Martinsried, Germany) and LabPMM GK (Kawasaki City, Japan). LeukoStrat CDx FLT3 Mutation Assay kits are currently distributed in Europe, will be available in Japan in 2018, and are planned for distribution in the United States, and China in the future.