Impact of the biomarker enrichment strategy in drug development.

Lara Gongora, Aline Bobato; Carvalho Oliveira, Leandro Jonata; Jardim, Denis Leonardo

Lara Gongora, Aline Bobato; Carvalho Oliveira, Leandro Jonata; Jardim, Denis Leonardo.

Afiliação

Lara Gongora AB; Oncology Center, Hospital Sírio-Libanês , São Paulo, Brazil.
Carvalho Oliveira LJ; Oncology Center, Hospital Sírio-Libanês , São Paulo, Brazil.
Jardim DL; Oncology Center, Hospital Sírio-Libanês , São Paulo, Brazil.

Expert Rev Mol Diagn ; 20(6): 611-618, 2020 06.

Article em En | MEDLINE | ID: mdl-31903795

RESUMO

INTRODUCTION: Recently, new oncology therapies were developed using a biomarker for patient selection. In the era of cancer genomics, this paradigm is expected to increase. Most cytotoxic chemotherapies and other oncological treatments were historically approved without a biomarker. However, this strategy seems to be less efficient. We reviewed the biomarker-based strategy and its impact in cancer drug development. AREAS COVERED: Oncology drugs approval rates are low and most of the drugs that failed to be approved were in late stages of development. In addition to that, attrition rates are high. The use of biomarkers in drug development has shown higher response rates, longer progression-free survival rates and even higher overall survival rates. Hence, the biomarker-based strategy seems to be associated with more successful drug programs, including a shorter timeline and higher likelihood of success. EXPERT OPINION: Even though the development of biomarker-driven strategies is promising, there are some challenges surrounding this field of study, such as reducing the cost of drug development, enhancing the technique of biomarkers identification (aiming more specific biomarkers and considering tumor heterogeneity) and exploring the role of next-generation sequencing tests in drug development. Also, collaboration between clinicians, scientists and regulatory agencies is fundamental.

Assuntos

Antineoplásicos/uso terapêutico; Biomarcadores Tumorais; Desenvolvimento de Medicamentos/métodos; Terapia de Alvo Molecular; Neoplasias/tratamento farmacológico; Medicina de Precisão/métodos; Antineoplásicos/economia; Antineoplásicos/farmacologia; Inteligência Artificial; Biomarcadores Tumorais/análise; Biomarcadores Tumorais/antagonistas & inibidores; Biomarcadores Tumorais/genética; Ensaios Clínicos como Assunto/métodos; Análise Mutacional de DNA; Aprovação de Drogas; Desenvolvimento de Medicamentos/tendências; Sequenciamento de Nucleotídeos em Larga Escala; Humanos; Inibidores de Checkpoint Imunológico/uso terapêutico; Colaboração Intersetorial; Metanálise como Assunto; Técnicas de Diagnóstico Molecular; Terapia de Alvo Molecular/economia; Terapia de Alvo Molecular/métodos; Neoplasias/química; Neoplasias/genética; Seleção de Pacientes; Fatores de Tempo; Estados Unidos; United States Food and Drug Administration

Palavras-chave

Biomarker; Clinical trials; Drug development; Personalized therapy; Precision oncology

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Biomarcadores Tumorais / Medicina de Precisão / Terapia de Alvo Molecular / Desenvolvimento de Medicamentos / Neoplasias / Antineoplásicos Tipo de estudo: Diagnostic_studies / Prognostic_studies / Systematic_reviews Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Expert Rev Mol Diagn Assunto da revista: BIOLOGIA MOLECULAR Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido

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