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The European Commission Approves Astellas’ XOSPATA® for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation Detected by Validated Tests, Including the Invivoscribe LeukoStrat CDx FLT3 Mutation Assay

The European Commission Approves Astellas’ XOSPATA® for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation Detected by Validated Tests, Including the Invivoscribe LeukoStrat CDx FLT3 Mutation Assay

SAN DIEGO, Dec. 5 (Korea Bizwire) — For twenty-five years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality, standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. The LeukoStrat® CDx FLT3 Mutation Assay may now be used as an aid in the assessment of AML patients for treatment with XOSPATA® (gilteritinib) [...]

Update — US FDA Approves Invivoscribe LeukoStrat CDx FLT3 Mutation Assay as CDx and Astellas Drug XOSPATA (gilteritinib fumarate) for Treatment of AML Patients in the US

Update — US FDA Approves Invivoscribe LeukoStrat CDx FLT3 Mutation Assay as CDx and Astellas Drug XOSPATA (gilteritinib fumarate) for Treatment of AML Patients in the US

SAN DIEGO, Nov. 29 (Korea Bizwire) — 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 [...]