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US FDA approves Invivoscribe LeukoStrat CDx FLT3 Mutation Assay as CDx and Astellas drug XOSPATA (gilteritinib fumarate) for treatment of AML patients in the USSAN DIEGO, Nov. 29, 2018 (GLOBE NEWSWIRE) -- Invivoscribe is pleased to announce FDA approval of both the LeukoStrat CDx FLT3 Mutation Assay and the Astellas drug, XOSPATA (gilteritinib fumarate), for treatment of FLT3 positive refractory/relapse acute myeloid leukemia (AML) patients in the US. Further, the Japanese MHLW has confirmed national reimbursement for the LeukoStrat CDx FLT3 Mutation Assay in Japan. 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, VANFLYTA (quizartinib hydrochloride). This milestone further establishes the LeukoStrat CDx FLT3 Mutation Assay as the international gold standard for comprehensive FLT3 assessmentfor 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. About the Invivoscribe LeukoStrat CDx FLT3 Mutation Assay 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. About Invivoscribe For additional information please contact Invivoscribe at [email protected] or visit www.invivoscribe.com. |