A review of clinical pharmacology considerations in antibody-drug conjugates approved by the US Food and Drug Administration between 2000 and 2025
Seoyoung Koo, Chae Yeon Kim, Jeong-hyeon Lim, Eunyoung Lee, In Young Kim, Young G. Shin, Hanlim Moon · 2025
Read A review of clinical pharmacology considerations in antibody-drug conjugates approved by the US Food and Drug Administration between 2000 and 2025 by Seoyoung Koo, Chae Yeon Kim, Jeong-hyeon Lim, Eunyoung Lee, In Young Kim, Young G. Shin, Hanlim Moon (2025) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-12806659.txt.
Description
Koo and co-authors read twenty-five years of regulatory files to learn what the FDA really asks of antibody-drug conjugates. These cancer drugs, antibodies ferrying toxic payloads, are pharmacologically tricky, and approval files reveal the pattern. The review covers all thirteen conjugates approved by March 2025 and scores them against six topics from the agency's 2024 guidance.
All six topics were applied consistently long before the guidance existed. The toughest scrutiny lands on exposure-response judgments where safety is at stake, on patient factors such as liver impairment and race, and on validated tests for immune reactions to the drug. Those topics repeatedly trigger post-marketing requirements. The authors advise developers to align early with these expectations to avoid delays.
Catalog record
| CREATOR | Seoyoung Koo, Chae Yeon Kim, Jeong-hyeon Lim, Eunyoung Lee, In Young Kim, Young G. Shin, Hanlim Moon |
|---|---|
| YEAR | 2025 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 53 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |