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 [...]