Abstract
Identification of new disease-associated biomarkers; specific targeting of such markers by monoclonal antibodies (mAbs); and application of advances in recombinant technology, including the production of humanized and fully human antibodies, has enabled many improved treatment outcomes and successful new biological treatments of some diseases previously neglected or with poor prognoses. Of the 110 mAbs preparations currently approved by the FDA and/or EMA, 46 (including 13 antibody–drug conjugates) recognizing 29 different targets are indicated for the treatment of cancers, and 66, recognizing 48 different targets, are indicated for non-cancer disorders. Despite their specific targeting with the expected accompanying reduced collateral damage for normal healthy non-involved cells, mAbs, may cause types I (anaphylaxis, urticaria), II (e.g., hemolytic anemia, possibly early-onset neutropenia), III (serum sickness, pneumonitis), and IV (Stevens–Johnson syndrome, toxic epidermal necrolysis) hypersensitivities as well as other cutaneous, pulmonary, cardiac, and liver adverse events. MAbs can provoke severe infusion reactions that resemble anaphylaxis and induce a number of systemic, potentially life-threatening syndromes with low frequency. A common feature of most of these syndromes is the release of a cascade of cytokines associated with inflammatory and immunological processes. Epidermal growth factor receptor-targeted antibodies may provoke papulopustular and mucocutaneous eruptions that are not immune-mediated.
Highlights
In the last decade, along with the continuing development of the disciplines of genomics, proteomics, and bioinformatics and the application of molecular biological approaches to elucidate the functions of single genes, advances have led to insights into the complexities and multifaceted nature of diseases such as cancer, immune and inflammatorybased diseases, metabolic disorders, neurological diseases, transplantation, and some poorly understood dermatologic toxicities [1–6]
Specific, targeted approaches employed in many monoclonal antibody, fusion protein, and cytokine therapies have been enabled by advances in recombinant DNA technology, the preparation of human recombinant antibody libraries, today’s sequencing methods, parallel proteome analyses employing techniques such as mass spectroscopy, and single B cell technologies [5–7]
At the beginning of 2022, the catalog of monoclonal antibodies (mAbs) approved for therapy by the Food and Drug Authority (FDA) and/or European Medicines Agency (EMA) consisted of 66 approved for non-cancer indications and 46 for cancer therapy
Summary
Along with the continuing development of the disciplines of genomics, proteomics, and bioinformatics and the application of molecular biological approaches to elucidate the functions of single genes, advances have led to insights into the complexities and multifaceted nature of diseases such as cancer, immune and inflammatorybased diseases, metabolic disorders, neurological diseases, transplantation, and some poorly understood dermatologic toxicities [1–6]. The U.S Food and Drug Authority (FDA) Office of Orphan Products Development and its European equivalent have provided extra stimulus for the development of therapies for “orphan diseases”, that is, diseases with less than 200,000 patients [8]. This stimulus has led to the introduction of effective approved mAb therapies for some diseases with low patient numbers previously neglected because of the lack of pathogenetic and pathophysiological insights into rare disorders where the potentially small market often precluded investigations [9]. Focus is directed to the classification of the 110 mAbs, their antibody targets, approved disease indications, and the adverse events associated with their use
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