Radioimmunotherapy in Non-Hodgkin's Lymphoma: Retrospective Adverse Event Profiling of Zevalin and Bexxar.

Sachpekidis, Christos; Jackson, David B; Soldatos, Theodoros G (2019). Radioimmunotherapy in Non-Hodgkin's Lymphoma: Retrospective Adverse Event Profiling of Zevalin and Bexxar. Pharmaceuticals, 12(4) MDPI 10.3390/ph12040141

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The development of monoclonal antibodies has dramatically changed the outcome of patients with non-Hodgkin's lymphoma (NHL), the most common hematological malignancy. However, despite the satisfying results of monoclonal antibody treatment, only few NHL patients are permanently cured with single-agent therapies. In this context, radioimmunotherapy, the administration of radionuclides conjugated to monoclonal antibodies, is aimed to augment the single-agent efficacy of immunotherapy in order to deliver targeted radiation to tumors, particularly CD20+ B-cell lymphomas. Based on evidence from several trials in NHL, the radiolabeled antibodies 90Y-ibritumomab tiuxetan (Zevalin, Spectrum Pharmaceuticals) and 131I-tositumomab (Bexxar, GlaxoSmithKline) received FDA approval in 2002 and 2003, respectively. However, none of the two radioimmunotherapeutic agents has been broadly applied in clinical practice. The main reason for the under-utilization of radioimmunotherapy includes economic and logistic considerations. However, concerns about potential side effects have also been raised. Driven by these developments, we performed retrospective analysis of adverse events reporting Zevalin or Bexxar, extracted from the FDA's Adverse Event Reporting System (FAERS) and the World Health Organization's VigiBase repository. Our results indicate that the two radioimmunotherapeutic agents have both related and distinct side effect profiles and confirm their known toxicological considerations. Our work also suggests that computational analysis of real-world post-marketing data can provide informative clinical insights. While more prospective studies are necessary to fully characterize the efficacy and safety of radioimmunotherapy, we expect that it has not yet reached its full therapeutic potential in modern hematological oncology.

Item Type:

Journal Article (Original Article)


04 Faculty of Medicine > Department of Radiology, Neuroradiology and Nuclear Medicine (DRNN) > Clinic of Nuclear Medicine

UniBE Contributor:

Sachpekidis, Christos


600 Technology > 610 Medicine & health








Sabine Lanz

Date Deposited:

18 Dec 2019 09:29

Last Modified:

18 Dec 2019 09:29

Publisher DOI:


PubMed ID:


Uncontrolled Keywords:

90Y-ibritumomab tiuxetan (Zevalin), 131I-tositumomab (Bexxar), FDA’s Adverse Event Reporting System (FAERS), VigiBase non-Hodgkin’s lymphoma radioimmunotherapy




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