midostaurin
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 Garners CE Mark for LeukoStrat CDx FLT3 Mutation Assay
The test is intended to detect FLT3 mutations in order to select patients for treatment with Novartis' Rydapt, and has also been approved by the US FDA.
FDA Approves Rx/Dx Combination for Acute Myeloid Leukemia
The agency approved Novartis' Rydapt for AML patients with FLT3 mutations, who will be identified by Invivoscribe's LeukoStrat CDx.
Invivoscribe and Novartis plan to develop an FDA-approved companion test for the investigational AML drug midostaurin and simultaneously launch the drug/test combination worldwide.