Individualizing Therapy of Monoclonal Antibodies and Fusion Proteins: Emerging Potential in the Age of Personalized Medicine

Abstract

Personalized medicine is an emerging and promising alternative to standard therapy regimens with the potential to significantly influence therapeutic interventions for many diseases. An extensive literature review of studies that focused on pharmacogenomics of monoclonal antibodies (mAbs) and immunoglobulin-containing fusion proteins (igFPs) was conducted. A comprehensive survey of the US FDA-approved labels revealed that pharmacogenomics information has also been incorporated into the label of some mAbs to guide therapy. In addition, treatment-emergent adverse events for mAbs and igFPs were analyzed that showed an association with the drugs‘ individual mechanism of action as well as molecular nature. The identification of the signaling pathways linked to the specific target of each mAb or igFP may help accelerate clinical successes in predicting and managing treatment-associated severe adverse events in individual patients. Incorporating pharmacogenomics into drug development of mAbs and igFPs will improve treatment efficacy, and may allow prediction of adverse events. Thus, a promising future of personalized medicine for these therapeutics is predicted.

Disclaimer

The views expressed are those of the authors and do not necessarily reflect the official policy of the US FDA. No official endorsement is intended or should be inferred.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.