gilteritinib
Japanese Regulators Approve Invivoscribe Assay as CDx for Daiichi Sankyo AML Drug
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.
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.
Invivoscribe CDx Assay Gets Expanded FDA Approval Alongside Astellas AML Drug
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 Submits FLT3 Mutation CDx Assay to FDA
Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.
Invivoscribe Submits FLT3 Mutation Assay CDx to Japanese Regulators
The company submitted the test to Japanese regulators for approval as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.