Review of Clinical Pharmacology Considerations for ADCs Approved by the FDA from 2000 to 2025.

MediRama announced on the 14th that a paper authored by its medical and scientific affairs team—including CEO Hanlim Moon and Executive Director Inyoung Kim—has been published in Translational and Clinical Pharmacology (TCP).

The title of the paper is “A Review of Clinical Pharmacology Considerations for Antibody–Drug Conjugates (ADCs) Approved by the U.S. Food and Drug Administration (FDA) from 2000 to 2025.” The study analyzes regulatory review documents for 13 ADCs approved by the FDA between 2000 and March of last year.

According to the paper, even before the release of the FDA’s official guidance in 2024, the agency had consistently and rigorously evaluated six core clinical pharmacology domains:
△ bioanalysis
△ exposure–response relationships
△ intrinsic factors
△ extrinsic factors
△ QTc
△ immunogenicity

In particular, exposure–response relationships, intrinsic factors, and immunogenicity were repeatedly identified as major regulatory issues and frequently led to post-marketing requirements or commitments (PMR/PMC) for multiple ADCs. The authors highlight that thorough early-stage preparation in these areas can help reduce approval delays and post-marketing obligations during ADC development.

Key insights from the paper include:

• The FDA often independently re-evaluates submitted data rather than accepting sponsors’ analyses at face value, frequently redefining conclusions with a strong emphasis on methodological rigor.

• Regulatory flexibility is applied only conditionally, and PMR/PMC are consistently imposed when safety-related uncertainties remain.

• Securing patient population diversity and implementing precision dosing are becoming increasingly important regulatory priorities, serving as key factors that shape regulatory expectations for next-generation ADCs.

MediRama stated, “This paper suggests that proactively addressing areas that are repeatedly highlighted by regulators from the early stages of development can accelerate regulatory approval,” adding that it also confirms such efforts can help ensure safer access to complex therapies for a broader patient population.

Source: https://www.thebionews.net