On October 30, 2019 Invivoscribe Inc. reported that the European Commission (EC) has granted regulatory approval for the Astellas drug XOSPATA (gilteritinib) (Press release, Invivoscribe Technologies, OCT 30, 2019, View Source;825237203.html [SID1234550074]). This is a monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations ( FLT3 mut +), which discovers from the Invivo leukostrat CDx FLT3 mutation assay can be.

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The LeukoStrat test is available as a test menu service through the subsidiaries of Invivoscribe LabPMM LLC ( San Diego , California, USA ), LabPMM GmbH (Martinsried, Germany), and LabPMM GK ( Kawasaki, Japan ). Test kits of the LeukoStrat CDx FLT3 mutation assay are currently distributed in Europe, Japan , Switzerland and Australia and are expected to be available in the United States and China in the future .

Invivoscribe has developed the LeukoStrat CDx FLT3 Mutation Assay in collaboration with Astellas as a companion diagnostic to predict patient response to Astellas Pharma’s AOS drug XOSPATA (gilteritinib fumarate). The current approval is based on the results of the Phase 3 ADMIRAL study in which gilteritinib is compared to second-line chemotherapy in patients with relapsed or refractory FLT3mut + -AML was investigated. There was a significantly higher Overall Survival (OS) in patients treated with gilteritinib than those who received second-line chemotherapy. The mean OS for patients receiving gilteritinib was 9.3 months, compared to 5.6 months for patients treated with second-line chemotherapy alone.

With this milestone, the LeukoStrat CDx FLT3 Mutation Assay can continue to establish itself as an international gold standard for comprehensive FLT3 assessment of critically ill AML patients. This is especially true because this CDx can identify both ITD and TKD FLT3 mutations (including large internal tandem duplications) and is globally available.

This approval completes the series of regulatory approvals previously received by Invivoscribe for the LeukoStrat CDx FLT3 mutation assay as an adjunctive diagnostic for Astellas XOSPATA (gilteritinib fumarate), Novartis RYDAPT (midostaurine) and Daichi Sankyo quizartineib hydrochloride.

"The approval by the European Commission is a significant forest step for patients with relapsed or refractory FLT3 mutation-positive acute myeloid leukemia. Invivoscribe looks forward to additional treatment options that can extend the lives of patients, and the company looks forward to partnering with other pharmaceutical companies interested in using our Streamlined CDx program, whether its therapies for hematologic disease or cancer targeting solid tumors to accelerate drug approvals worldwide, "said Jeffrey Miller , CSO and CEO of Invivoscribe .

About the Invivoscribe LeukoStrat CDx FLT3 Mutation Assay
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test that incorporates internal tandem duplication (ITD) mutations and the D835 and I836 mutations in the Tyrosine kinase domain (TKD) can be detected in the FLT3 gene. The gene is derived from genomic DNA extracted from mononuclear cells derived from peripheral blood or bone marrow aspirate from patients diagnosed with acute myeloid leukemia.

The LeukoStrat CDx FLT3 Mutation Assay is used as a tool to evaluate patients with AML who are considering treatment with Midostaurin (United States, Europe, Switzerland and Australia).

The LeukoStrat CDx FLT3 Mutation Assay is used as a tool to evaluate patients with AML who are considering treatment with gilteritinib fumarate (United States, Europe and Japan ).

The LeukoStrat CDx FLT3 mutation assay is used as a tool to evaluate patients with AML who are considering treatment with quizartineib hydrochloride ( Japan ).

The globally standardized test includes software that interprets data and determines the respective mutant / wild-type signal quotient for ITD and TKD mutations. This extensively tested assay helps standardize the discovery of genetic mutations in the FLT3 gene, which is one of the major causes of mutations in acute myeloid leukemia (AML).