ABSTRACT

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.

中文翻译：

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生物标志物富集策略对药物开发的影响。

摘要

介绍

最近，使用用于患者选择的生物标志物开发了新的肿瘤疗法。在癌症基因组学时代，这种范式有望增加。大多数细胞毒性化学疗法和其他肿瘤治疗在历史上都是在没有生物标志物的情况下获得批准的。然而，这种策略似乎效率较低。我们回顾了基于生物标志物的策略及其在癌症药物开发中的影响。

覆盖区域

肿瘤药物批准率低，大部分未获批准的药物处于开发后期。除此之外，流失率也很高。在药物开发中使用生物标志物显示出更高的反应率、更长的无进展生存率和更高的总生存率。因此，基于生物标志物的策略似乎与更成功的药物计划有关，包括更短的时间线和更高的成功可能性。

专家意见

尽管生物标志物驱动策略的发展前景广阔，但围绕这一研究领域仍存在一些挑战，例如降低药物开发成本、增强生物标志物识别技术（针对更具体的生物标志物并考虑肿瘤异质性）以及探索下一代测序测试在药物开发中的作用。此外，临床医生、科学家和监管机构之间的合作至关重要。