Interpretation of pharmacokinetic-based criteria for supporting alternative dosing regimens of programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies for treatment of patients with cancer guidance for industry
10.12092/j.issn.1009-2501.2022.01.012
- Author:
Wei LIU
1
;
Ziyu WANG
1
;
Junsheng XUE
2
;
Rong CHEN
2
;
Tianyan ZHOU
2
;
Zhiheng YU
3
Author Information
1. Peking University Third Hospital, Department of Pharmacy
2. Department of Pharmaceutics, School of Pharmaceutical Sciences, Peking University
3. Peking University Third Hospital, Department of Obstetrics and Gynecology
- Publication Type:Journal Article
- Keywords:
Model simulation;
Model-informed drug development;
Pharmacometrics;
Population pharmacokinetics
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2022;27(1):86-94
- CountryChina
- Language:Chinese
-
Abstract:
In recent years, modeling and simulation technology based on pharmacometrics has received increasing attention in the development of innovation drugs. In August of 2021, FDA issued a guidance named Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer Guidance for Industry, claiming the necessity of using population PK-based simulation method for the optimization of dosing regimens, and the corresponding implementation standards. This article first summarized the existing therapeutic regimens of PD-1/PD-L1 blocking antibodies in clinic as well as the main content of the guidance, and then cited some actual examples where population PK-based simulation method did contribute to the approval of the alternative dosing regimens. Besides, some critical considerations for the dosing regimen optimization of PD-1/PD-L1 blocking antibodies were also analyzed. In our view, this guidance would have positive impacts on the development of PD-1/PD-L1 blocking antibodies in the future. We hope that this article may provide some references for the colleagues in China.
