Navigating Recent Changes in Dosing Information: Dynamics of FDA-Approved Monoclonal Antibodies in Post-Marketing Realities

Abstract

Monoclonal antibodies (mAbs) are critical components in the therapeutic landscape, but their dosing strategies often evolve post-approval as new data emerge. This review evaluates post-marketing label changes in dosing information for FDA-approved mAbs from January 2015 to September 2024, with a focus on both initial and extended indications. We systematically analyzed dosing modifications, categorizing them into six predefined groups: Dose increases or decreases, inclusion of new patient populations by body weight or age, shifts from body weight-based dosing to fixed regimens, and adjustments in infusion rates. Among the 86 mAbs evaluated, 21% (n = 18) exhibited changes in dosing information for the initial indication, with a median time to modification of 37.5 months (range: 5–76 months). Furthermore, for mAbs with extended indications (n = 26), 19.2% (n = 5) underwent dosing changes in their first extensions, with a median time to adjustment of 31 months (range: 8–71 months). Key drivers for these adjustments included optimizing therapeutic efficacy, addressing safety concerns, accommodating special populations, and enhancing patient convenience. We also discuss the role of model-informed drug development, real-world evidence, and pharmacogenomics in refining mAb dosing strategies. These insights underscore the importance of ongoing monitoring and data integration in the post-marketing phase, providing a foundation for future precision medicine approaches in mAb therapy.