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Gilteritinib (Astellas Pharma's Xospata) is intended to treat relapsed or refractory acute myeloid leukemia patients with a FLT3 mutation.
The drug has shown in clinical trials to improve outcomes in patients with FLT3 internal tandem duplication and tyrosine kinase domain mutations.
The phase III trial saw significant overall survival and remission rates in relapsed or treatment refractory acute myeloid leukemia cases treated with the FLT3 inhibitor gilteritinib.
The drug, which has already been approved for marketing in the US and Japan, will now be reviewed by for potential approval in the European Union.
The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.
Researchers used Mission Bio's Tapestri assay to identify and monitor the evolution of cancer mutations in acute myeloid leukemia in response to targeted treatment.
Results from the phase 3 ADMIRAL trial were announced during the American Association for Cancer Research annual meeting.
The VA decided to bring this testing in house to streamline and standardize the process for doctors and gauge markers that are relevant to the veteran population.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test for internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.
Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.