General considerations for clinical pharmacology of antitumor antibody-conjugated drugs: Implications from FDA review cases
10.12092/j.issn.1009-2501.2023.01.010
- Author:
Lili GAO
1
;
Yuzhu WANG
1
;
Yan WANG
1
;
Jian LI
1
;
Jun WANG
1
Author Information
1. Center for Drug Evaluation, NMPA
- Publication Type:Journal Article
- Keywords:
antibody-drug conjugates;
antitumor;
clinical pharmacology;
FDA
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2023;28(1):75-85
- CountryChina
- Language:Chinese
-
Abstract:
Antibody-drug conjugates (ADCs) are conjugated by a linker between an antibody drug targeting a specific antigen and a payload, such as a small cytotoxic drug. ADCs combine the potent killing effect of traditional small cytotoxic drugs with the tumor targeting property of antibody drugs. As of February 2022, the U.S. Food and Drug Administration (FDA) had approved 12 ADC antitumor agents. Based on the analysis of clinical pharmacology review reports of approved ADC drugs combined with relevant guidelines, it is found that in the development of ADC, in addition to the general research in clinical pharmacology, there are special considerations in dose selection and dose modification for special population due to the special anti-tumor mechanism of ADC. It is hoped that this paper will be enlightening to domestic researchers when developing ADC.
