On October 30, 2019 Invivoscribe, Inc. reported that the European Commission (EC) has proceeded to authorize the drug Astellas XOSPATA (gilteritinib) as monotherapy for the treatment of adults affected by leukemia Recurrent or refractory acute myeloid (AML) presenting FLT3 mutations ( FLT3 mut +) detected with the LeukoStrat CDx FLT3 mutation analysis (Press release, Invivoscribe Technologies, OCT 30, 2019, View Source [SID1234550067]).
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The LeukoStrat test is presented as a service that comprises a range of determinations and is marketed through several subsidiaries of Invivoscribe: LabPMM LLC, of San Diego ( California , USA); LabPMM GmbH, of Martinsried (Germany), and LabPMM GK, of Kawasaki (Japan). Currently, lots of CDx FLT3 mutation analysis are also distributed in Europe, Japan, Switzerland and Australia and it is planned to do so, in the future, in the United States and China .
Invivoscribe developed the LeukoStrat CDx FLT3 , in collaboration with Astellas, as an accompanying diagnostic test that allows predicting the patient’s response to the drug XOSPATA (Gilteritinib fumarate), from Astellas, for AML. The authorization that has just been granted is based on the results of the ADMIRAL phase III trial, in which gilteritinib was studied in comparison to rescue chemotherapy in patients with relapsing or refractory FLT3 AML . Thus, patients treated with gilteritinib had a markedly greater overall survival (OS) than those who received rescue chemotherapy: the median of OS was, in the case of the first, 9.3 months, compared with 5.6 of the patients who were only given chemotherapy.
Such a milestone consolidates the position of the LeukoStrat CDx FLT3 mutation analysis as a reference method of general evaluation of the FLT3 gene in critically ill patients of AML, since this accompanying diagnostic test allows FLT3 mutations in the tyrosine kinase domain (DTC) to be identified. and that show internal tandem duplication (DIT). LeukoStrat is marketed internationally.
This authorization is complementary to the others that have already been granted by the health authorities to the analysis of the LeukoStrat CDx FLT3 mutation as an accompanying diagnostic method of XOSPATA (Gilteritinib fumarate) from Astellas; RYDAPT (midostaurin) from Novartis, and quizartinib hydrochloride from Daiichi Sankyo.
"The authorization of the European Commission constitutes a notable advance for patients with recurrent or refractory acute myeloid leukemia with a FLT3 mutation . In Invivoscribe we welcome the introduction of more therapeutic options that allow the patient to be extended and we would be delighted to partner with pharmaceutical laboratories interested in taking advantage of our Streamlined CDx program with a view to speeding up obtaining authorization for their drugs in different parts of the world, regardless of whether the treatments in question are aimed at hemopathies or solid tumors, "said Jeffrey Miller , director of Strategy and CEO of Invivoscribe.
About the LeukoStrat CDx FLT3 mutation analysis of Invivoscribe
The LeukoStrat CDx
FLT3 mutation analysis is an in vitro diagnostic test for PCR designed to detect mutations in D835 and I836 with internal tandem duplication (DIT) and in the tyrosine kinase domain (DTC) ) of the FLT3 gene , a detection that is performed on genomic DNA extracted from mononuclear cells taken from peripheral blood or bone marrow aspirates from patients who have been diagnosed with acute myelogenous leukemia.
The LeukoStrat CDx FLT3 mutation analysis is used as an auxiliary system for the evaluation of patients with AML for those considering the possibility of starting treatment with midostaurin (in the United States, Europe, Switzerland and Australia ),
The LeukoStrat CDx FLT3 mutation analysis is used as an auxiliary system for the evaluation of patients with AML for those considering the possibility of starting treatment with gilteritinib fumarate (in the United States, Europe and Japan).
The LeukoStrat CDx FLT3 mutation analysis is used as an auxiliary system for the evaluation of patients with AML for those considering the possibility of starting treatment with quizartinib hydrochloride (in Japan).
The international standardized test includes software that interprets the data and generates signal ratios of mutant and natural alleles corresponding to mutations with DIT and in the DTC. This widely validated analysis makes it possible to standardize the detection of genetic mutations in the FLT3 gene , which are among the most important oncogenic initiators of acute myeloid leukemia (AML).