European Commission Approves Astellas' XOSPATA(TM) for Patients with Relapsed or Refractory Acute Myeloid Leukemia with Mutations Detected using
SAN DIEGO, Oct. 30, 2019 /PRNewswire/ — Invivoscribe, Inc. announced today that the European Commission (EC) has approved the Astellas drug XOSPATA((TM)) (gilteritinib) as a monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations (FLT3mut+) detected using Invivoscribe’s LeukoStrat(®) CDx FLT3 Mutation Assay.
The LeukoStrat test is available as a test menu service through the Invivoscribe subsidiaries, LabPMM LLC (San Diego, CA, US), LabPMM GmbH (Martinsried, Germany), and LabPMM GK (Kawasaki City, Japan). LeukoStrat CDx FLT3 Mutation Assay kits are also currently distributed in Europe, in Japan, in Switzerland, in Australia, and are planned for distribution in the United States and China in the future.
Invivoscribe developed the LeukoStrat CDx FLT3 Mutation Assay in partnership with Astellas as the companion diagnostic to predict patient responses to Astellas Pharma’s AML drug XOSPATA (gilteritinib fumarate). This approval is based on results from the Phase 3 ADMIRAL trial, which investigated gilteritinib versus salvage chemotherapy in patients with relapsed or refractory FLT3mut+ AML. Patients treated with gilteritinib had significantly longer overall survival (OS) than those who received salvage chemotherapy. Median OS for patients who received gilteritinib was 9.3 months, compared to 5.6 months for patients who received salvage chemotherapy alone.
This milestone further establishes the LeukoStrat CDx FLT3 Mutation Assay as the international gold standard for comprehensive FLT3 assessment for critically ill AML patients as this CDx identifies both ITD and TKD FLT3 mutations (including large internal tandem duplications) and is available worldwide.
This approval complements Invivoscribe’s prior regulatory approvals of the LeukoStrat CDx FLT3 Mutation Assay as the companion diagnostic for XOSPATA (gilteritinib fumarate) for Astellas, RYDAPT (midostaurin) for Novartis, and quizartinib hydrochloride for Daichi Sankyo.
“Approval by the European Commission marks a significant advance for patients with relapsed or refractory, FLT3 mutation-positive acute myeloid leukemia. Invivoscribe is excited to see more treatment options available to extend patient’s lives, and welcomes partnerships with pharmaceutical companies interested in leveraging our Streamlined CDx((TM)) program to accelerate worldwide drug approvals, whether their therapies are targeting hematologic diseases or solid tumors,” said Jeffrey Miller, Invivoscribe’s CSO and CEO.
About the Invivoscribe LeukoStrat CDx FLT3 Mutation Assay The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based, in vitro diagnostic test designed to detect internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia.
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom Midostaurin (United States, Europe, Switzerland, and Australia) treatment is being considered.
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom Gilteritinib Fumarate (United States, Europe, and Japan) treatment is being considered.
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom Quizartinib Hydrochloride (Japan) treatment is being considered.
This globally standardized test includes software that interprets data, generates mutant/wildtype signal ratios for ITD and TKD mutations. This extensively validated assay helps standardize the detection of genetic mutations in the FLT3 gene as one of the most important driver mutations in Acute Myeloid Leukemia (AML).
About Invivoscribe Invivoscribe is a privately held biotechnology company dedicated to Improving Lives with Precision Diagnostics(®). For nearly twenty-five years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality, standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies interested in developing and commercializing companion diagnostics, and provides expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization.
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