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Since the Food and Drug Administration (FDA) approval of rituximab as the first monoclonal antibody (mAb) for cancer treatment, several mAbs and antibody (Ab)\u2010based therapies have been approved for the treatment of solid tumour malignancies and other cancers. These Abs function by either blocking oncogenic pathways or angiogenesis, modulating immune response, or by delivering a conjugated drug. The use of Ab\u2010based therapy in cancer patients who could benefit from the treatment, however, is still limited by associated toxicity profiles which may stem from biological features and processes related to target binding, alongside biochemical and\/or biophysical characteristics of the therapeutic Ab. A significant immune\u2010related adverse event (irAE) associated with Ab\u2010based therapies is cytokine release syndrome (CRS), characterized by the development of fever, rash and even marked, life\u2010threatening hypotension, and acute inflammation with secondary to systemic uncontrolled increase in a range of pro\u2010inflammatory cytokines. Here, we review irAEs associated with specific classes of approved, Ab\u2010based novel cancer immunotherapeutics, namely immune checkpoint (IC)\u2010targeting Abs, bispecific Abs (BsAbs) and Ab\u2010drug\u2010conjugates (ADCs), highlighting the significance of harmonization in preclinical assay development for safety assessment of Ab\u2010based biotherapeutics as an approach to support and refine clinical translation.<\/jats:p>","DOI":"10.1111\/jcmm.18470","type":"journal-article","created":{"date-parts":[[2024,7,4]],"date-time":"2024-07-04T12:24:40Z","timestamp":1720095880000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Immune\u2010related adverse events of antibody\u2010based biological medicines in cancer therapy"],"prefix":"10.1111","volume":"28","author":[{"given":"Deepa","family":"Rajagopal","sequence":"first","affiliation":[{"name":"Immunotherapy, Biotherapeutics and Advanced Therapies Division, 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