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MediRama’s Analysis of the Characteristics of 13 ADCs Approved by the U.S. FDA Published in an International Academic Journal
- Writer:관리자
- Date:2026-01-26
- Source:Hankyung Bio Insight
MediRama’s research findings, which analyzed the clinical pharmacology aspects of antibody–drug conjugates (ADCs) approved by the U.S. Food and Drug Administration (FDA), have been published in an international academic journal.
On the 15th, MediRama announced that its Medical/Scientific Publications team published a paper titled “A Review of Clinical Pharmacology Considerations for ADCs Approved by the FDA from 2000 to 2025” in the international journal Translational and Clinical Pharmacology (TCP).
The paper presents an analysis of regulatory review documents for 13 ADCs approved by the FDA between 2000 and March 2025. It highlights that even before the FDA issued its official guidance in 2024, the agency had already been consistently and rigorously evaluating six key clinical pharmacology domains: bioanalytical assessments, exposure–response analysis, intrinsic factors, extrinsic factors, QTc assessment, and immunogenicity. In particular, exposure–response relationships, intrinsic factors, and immunogenicity assessments repeatedly emerged as major issues and were shown to trigger postmarketing requirements (PMRs) and postmarketing commitments (PMCs) for multiple ADCs. The study suggests that thoroughly addressing these areas from the early stages of development may help reduce regulatory approval delays as well as postmarketing obligations.
The paper also highlights the following key takeaways:
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The FDA often redefines conclusions independently by prioritizing methodological rigor, rather than accepting submitted data at face value.
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Regulatory flexibility is applied only conditionally, and when safety uncertainties remain, PMRs/PMCs are consistently imposed.
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Ensuring diversity in patient populations and implementing precision dosing are increasingly becoming top priorities, shaping regulatory expectations for next-generation ADCs.
A MediRama official stated, “If developers proactively resolve the repeatedly raised issues from the early stages of development, they may not only accelerate regulatory approval but also help ensure that more patients can safely access these therapies even in complex treatment settings.”