Gilead Sciences, Foster City, California, USA.
Genentech, South San Francisco, California, USA.
Clin Transl Sci. 2022 Aug;15(8):1818-1837. doi: 10.1111/cts.13312. Epub 2022 Jun 7.
Cancer immunotherapy has significantly advanced the treatment paradigm in oncology, with approvals of immuno-oncology agents for over 16 indications, many of them first line. Checkpoint inhibitors (CPIs) are recognized as an essential backbone for a successful anticancer therapy regimen. This review focuses on the US Food and Drug Administration (FDA) regulatory approvals of major CPIs and the evolution of translational advances since their first approval close to a decade ago. In addition, critical preclinical and clinical pharmacology considerations, an overview of the pharmacokinetic and dose/regimen aspects, and a discussion of the future of CPI translational and clinical pharmacology as combination therapy becomes a mainstay of industrial immunotherapy development and in clinical practice are also discussed.
癌症免疫疗法在肿瘤学领域显著推进了治疗模式，批准了超过 16 种免疫肿瘤药物的适应证，其中许多是一线适应证。检查点抑制剂（CPIs）被认为是成功抗癌治疗方案的重要支柱。本综述重点介绍了美国食品和药物管理局（FDA）对主要 CPIs 的监管批准，以及自近 10 年前首次批准以来转化进展的演变。此外，还讨论了关键性临床前和临床药理学考虑因素、药代动力学和剂量/方案方面的概述，以及随着联合治疗成为工业免疫治疗发展和临床实践的主要方式，CPIs 转化和临床药理学的未来。
