乳腺癌药物研发中的潜在生物标志物：生物标志物资格认定证据框架的应用。
Potential biomarkers in breast cancer drug development: application of the biomarker qualification evidentiary framework.
机构信息
Daiichi-Sankyo, Inc., Basking Ridge, NJ 07920, USA.
Rutgers Institute for Pharmaceutical Industry Fellowships, Piscataway, NJ 08854, USA.
出版信息
Biomark Med. 2024;18(6):265-277. doi: 10.2217/bmm-2023-0048. Epub 2024 Mar 15.
Abstract
Breast cancer treatments have evolved rapidly, and clinically meaningful biomarkers have been used to guide therapy. These biomarkers hold utility within the drug development process to increase the efficiency and effectiveness. To this purpose, the US FDA developed an evidentiary framework. Literature searches conducted of literature published between 2016 and 2022 identified biomarkers in breast cancer. These biomarkers were reviewed for drug development utility through the biomarker qualification evidentiary framework. In the breast cancer setting, several promising biomarkers (ctDNA, Ki-67 and PIK3CA) were identified. There is a need for increased transparency regarding the requirements for qualification of specific biomarkers and increased awareness of the processes involved in biomarker qualification.
摘要
乳腺癌治疗方法迅速发展，临床上有意义的生物标志物已被用于指导治疗。这些生物标志物在药物开发过程中具有实用性，可以提高效率和效果。为此，美国 FDA 制定了一个证据框架。对 2016 年至 2022 年期间发表的文献进行文献检索，确定了乳腺癌中的生物标志物。通过生物标志物资格证据框架对这些生物标志物在药物开发中的实用性进行了审查。在乳腺癌环境中，确定了几个有前途的生物标志物（ctDNA、Ki-67 和 PIK3CA）。需要提高对特定生物标志物资格要求的透明度，并提高对生物标志物资格所涉及过程的认识。
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