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Comissão Europeia aprova XOSPATA™ da Astellas para tratar pacientes com leucemia mieloide aguda recidiva ou refratária com mutações detectadas com o uso do ensaio de mutação LeukoStrat® CDx FLT3 da Invivoscribe
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News provided by

Invivoscribe, Inc.

Oct 30, 2019, 11:38 ET

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SAN DIEGO, 30 de outubro de 2019 /PRNewswire/ -- A Invivoscribe, Inc. anunciou hoje que a Comissão Europeia (CE) aprovou o medicamento XOSPATA™ (gilteritinibe) da Astellas como monoterapia para o tratamento de pacientes adultos com leucemia mieloide aguda (LMA) recidiva ou refratária detectada com o uso de ensaio de mutação LeukoStrat® CDx FLT3 da Invivoscribe.

O teste LeukoStrat está disponível como um serviço de menu de teste através das subsidiárias da Invivoscribe LabPMM LLC (San Diego, Califórnia, EUA), LabPMM GmbH (Martinsried, Alemanha) e LabPMM GK (Cidade de Kawasaki, Japão). Atualmente, os kits do Ensaio de Mutação LeukoStrat CDx FLT3 são distribuídos na Europa, Japão, Suíça e Austrália. Há planos de distribuição nos Estados Unidos e na China no futuro.

A Invivoscribe desenvolveu o Ensaio de Mutação LeukoStrat CDx FLT3 em parceria com a Astellas, como diagnóstico concomitante para predizer respostas do paciente ao medicamento XOSPATA (fumarato de gilteritinibe) para LMA da Astellas Pharma. Essa aprovação é baseada nos resultados do estudo clínico de Fase 3 ADMIRAL, que investigou o gilteritinibe versus a quimioterapia de salvamento em pacientes com FLT3mut+ LMA recidiva ou refratária. Pacientes tratados com gilteritinibe tiveram sobrevivência geral (OS – overall survival) significativamente mais longa do que os que foram tratados com quimioterapia de salvação. A sobrevivência geral média dos pacientes tratados com gilteritinibe foi de 9,3 meses, comparados com 5,6 meses dos pacientes tratados apenas com quimioterapia de salvação.

Esse marco estabelece ainda mais o Ensaio de Mutação LeukoStrat CDx FLT3 como o padrão ouro internacional para a avaliação abrangente do gene FLT3 de pacientes com LMA criticamente doentes, porque esse CDx identifica mutações ITD e TKD do FLT3 (incluindo grandes duplicações internas em tandem) e está disponível mundialmente.

Essa aprovação complementa as aprovações regulatórias anteriores para a Invivoscribe do Ensaio de Mutação LeukoStrat CDx FLT3 como o diagnóstico concomitante para o XOSPATA (fumarato de gilteritinibe) da Astellas, RYDAPT (midostaurina) da Novartis e hidrocloreto de quizartinibe da Daichi Sankyo.

"A aprovação pela Comissão Europeia representa um avanço significativo para pacientes com leucemia mieloide aguda recidiva ou refratária da mutação do FLT3 positiva. A Invivoscribe está muito satisfeita por ver mais opções de tratamento disponíveis para prolongar as vidas dos pacientes e celebra as parcerias com laboratórios farmacêuticos interessados em alavancar seu programa Streamlined CDx™ para acelerar aprovações do medicamento mundialmente, quer suas terapias visem doenças hematológicas, quer tumores sólidos", disse o diretor científico e presidente-executivo da Invivoscribe, Jeffrey Miller.

Sobre o Ensaio de Mutação LeukoStrat CDx FLT3 da Invivoscribe
O Ensaio de Mutação LeukoStrat CDx FLT3 é um teste de diagnóstico in vitro, baseado em PCR, criado para detectar mutações na duplicação interna em tandem (ITD – internal tandem duplication) e mutações no domínio da tirosina quinase (TKD – tyrosine kinase domain) D835 e I836 no gene FLT3 no DNA genômico extraído de células mononucleares obtidas do sangue periférico ou aspirações da medula óssea de pacientes diagnosticados com leucemia mielógena aguda.

O Ensaio de Mutação LeukoStrat CDx FLT3 é usado como apoio na avaliação de pacientes com LMA, para os quais o tratamento com midostaurina está em consideração (Estados Unidos, Europa, Suíça e Austrália).

O Ensaio de Mutação LeukoStrat CDx FLT3 é usado como apoio na avaliação de pacientes com LMA, para os quais o tratamento com fumarato de gilteritinibe está em consideração (Estados Unidos, Europa e Japão).

O Ensaio de Mutação LeukoStrat CDx FLT3 é usado como apoio na avaliação de pacientes com LMA, para os quais o tratamento com hidrocloreto de quizartinibe está em consideração (Japão).

Esse teste padronizado globalmente inclui software que interpreta dados, gera coeficientes de sinal mutante/tipo selvagem para mutações ITD e TKD. Esse ensaio extensivamente comprovado ajuda a padronizar a detecção de mutações genéticas no gene FLT3 como uma das mais importantes mutações causadoras da leucemia mieloide aguda (LMA).

Sobre a Invivoscribe
A Invivoscribe é uma empresa privada de biotecnologia dedicada a melhorar vidas com diagnóstico de precisão (Improving Lives with Precision Diagnostics®). Por quase 20 anos, a Invivoscribe aprimorou a qualidade do tratamento de saúde em todo o mundo, ao fornecer reagentes, testes e ferramentas de bioinformática padronizados de alta qualidade para promover o campo da medicina de precisão. A Invivoscribe tem um histórico bem-sucedido de parcerias com laboratórios farmacêuticos globais, interessados em desenvolver e comercializar diagnósticos concomitantes e fornece expertise e serviços regulatórios e laboratoriais. Ao fornecer kits distribuíveis, bem como serviços de estudo clínico, através de suas subsidiárias de laboratórios clínicos globais (LabPMM), a Invivoscribe é a parceira ideal para desenvolvimento de diagnósticos, através de estudos clínicos, requisições regulatórias e comercialização.

Para obter mais informações, contate a Invivoscribe pelo e-mail [email protected] ou visite www.invivoscribe.com.

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FONTE Invivoscribe, Inc.

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