title: 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.
authors: Office of Clinical Pharmacology, Center for Drug Evaluation & Research, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. christian.grimstein@fda.hhs.gov
authors: Christian
authors: C
authors: Grimstein
authors: Jane P F
authors: JP
authors: Bai
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D055808:Drug Discovery; D006801:Humans; D010597:Pharmacogenetics; D057285:Precision Medicine; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D015398:Signal Transduction
chemical_list: D000911:Antibodies, Monoclonal; D011993:Recombinant Fusion Proteins