Invivoscribe has submitted LeukoStrat CDx FLT3 mutation assay to both the US FDA and the Japan Pharmaceuticals and Medical Devices Agency (PMDA) as the companion diagnostic for its partner Daiichi Sankyo’s quizartinib.
Invivoscribe stated that this submission follows Daiichi Sankyo’s submission of applications to the FDA and the PMDA for quizartinib in the US and in Japan, respectively.
Invivoscribe has partnered with Daiichi Sankyo for developing the LeukoStrat CDx FLT3 mutation assay, as a companion diagnostic that bridges to the global phase 3 QuANTUM-R clinical trial (Europe, US, Asia excluding Japan) in patients with relapsed/refractory FLT3 ITD acute myeloid leukemia (AML).
Together, the QuANTUM-R clinical trial and open-label phase 2 study of quizartinib (Japan) support the Daiichi Sankyo New Drug Application (NDA) to Japan’s MHLW/PMDA and the FDA in the US for use of quizartinib for treating adult patients with relapsed/ refractory FLT3 ITD AML.
Invivoscribe also stated its Streamlined CDx program integrates with a range of CDx activities such as development, clinical trials support with rapid patient screening for enrollment, regulatory support and commercialization.
It also complements the company’s prior regulatory approvals of this LeukoStrat CDx FLT3 Mutation Assay as an AML diagnostic companion for Novartis’ midostaurin in the US and Europe and gilteritinib Astellas’ fumarate in Japan.
Astellas and Invivoscribe have also submitted applications for the drug and device to the CDER and CDRH, respectively, in the US.
Invivoscribe claims that with this submission, LeukoStrat CDx FLT3 mutation assay can be established as an international gold standard for comprehensive FLT3 assessment for critically ill acute myeloid leukemia patients as this CDx can identify large ITD mutations, it is available worldwide and can generate standardized signal ratios for both ITD and TKD mutations.
These criteria have result in consistent stratification of patients which can help prescribing doctors in identifying personalized therapy options for their patients and speed up accelerate new drug and therapy approvals by establishing homogeneous patient populations for clinical trials.
Invivoscribe chief scientific officer and CEO Jeffrey Miller said: “These LeukoStrat CDx FLT3 Mutation Assay submissions and continuing Daiichi Sankyo partnership represent significant milestones for our company. We welcome opportunities to partner with global pharmaceutical companies interested in developing and commercializing companion diagnostics, whether their therapies are targeting hematologic diseases or solid tumors.”