Impact of the biomarker enrichment strategy in drug development.
Expert Rev Mol Diagn
; 20(6): 611-618, 2020 06.
Article
em En
| MEDLINE
| ID: mdl-31903795
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.
Palavras-chave
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