OBJECTIVES

Cancer affected 15 million people in 2019 in the US. There has been an increase in the FDA approval of biologic products. Safety information for biologics used in oncology is limited. This study evaluated the reports of adverse events for oncology therapeutic biologics reported to the FDA Adverse Event Reporting System (FAERS) in the period January 1, 1999, to September 30, 2019.

METHODS

We conducted a retrospective analysis of FAERS publicly available data. All cases involving a single biologic with reported use for oncology in the US were included in the study. Reporting odds ratios (RORs) and 95% confidence intervals (CI) were used to identify signals of disproportionate reporting in adverse reactions among biologics used in oncology.

RESULTS

The analysis included 45 therapeutic biologics listed in FAERS. A total of 202,778 reported cases were listed for oncology therapeutic biologics in the FAERS database in the study period. Disproportionality reporting signals were detected for serious adverse events among patients using interferon alfa-2 (ROR [95%CI] = 26.63 [12.79, 55.42]), interferon beta-1a (ROR [95%CI] = 2.24 [2.10, 2.38]), interferon beta-1b (ROR [95%CI] = 3.16 [2.94, 3.40]). Among monoclonal antibodies products, disproportionality signals were found for the occurrence of serious adverse events with alemtuzumab (ROR [95%CI] = 2.92 [2.61-3.27]), atezolizumab (ROR [95%CI] = 1.55 [1.33-1.80]), and bevacizumab (ROR [95%CI] = 2.94 [2.76-3.12]). No disproportionality signals were detected for colony stimulating factors.

CONCLUSIONS

Potential safety signals for the several interferons and monoclonal antibodies were identified. Causal inferences cannot be determined through the use of signals detected from voluntary reporting systems. Evaluation of the long-term clinical effects and risks of therapeutic biologics is needed due to the increase in approvals, growing patient population, and the emphasis early initiation of biologics for cancer treatment.