KUALA LUMPUR, Nov 30 (Bernama) -- Invivoscribe Inc has received the US FDA approval of both the LeukoStrat CDx FLT3 Mutation Assay and the Astellas drug, XOSPATA (gilteritinib fumarate) for treatment of FLT3 positive refractory and relapse acute myeloid leukemia (AML) patients in the US.
In addition, the Japanese MHLW has also confirmed national reimbursement for the LeukoStrat CDx FLT3 Mutation Assay in Japan, a statement said.
The approval complements Invivoscribe’s prior regulatory approvals of the 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).
The 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 milestone further establishes the LeukoStrat CDx FLT3 Mutation Assay as the international gold standard for comprehensive FLT3 assessment for critically ill AML patients as the CDx identifies both ITD and TKD mutations which available worldwide.
Invivoscribe has 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).
It is a privately held biotechnology company that has improved the quality of healthcare worldwide by providing high quality, standardized reagents, tests and bioinformatics tools to advance the field of precision medicine. More details on www.invivoscribe.com.
-- BERNAMA
-- BERNAMA
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