Post-marketing safety evaluation of zanubrutinib: a real-world pharmacovigilance analysis based on the FAERS database.

Abstract

Background: Zanubrutinib has been demonstrated to have significant response rates and promising survival data in clinical trials. However, real-world adverse events still need to be ameliorated to facilitate rational clinical drug use.

Research design and methods: Adverse incident reports from October 2019 to March 2024 were extracted from the FDA's Adverse Event Reporting System (FAERS) database. Zanubrutinib-related adverse events were obtained after data cleaning and analysis with SAS 9.4. Four methods were utilized to calculate disproportionality and evaluate AE signals of zanubrutinib.

Result: At the system organ class (SOC) level, one SOC met the criteria of the four algorithms. At the preferred term (PT) level, most AEs are those already included in the product monograph, and no unexpected safety signals have been identified. Furthermore, the average time to onset of adverse events was 134.8 days, with a median time of 16.5 days. Adverse events occurred in 57.96% of cases within 1 month.

Conclusion: Compared to the adverse events reported in clinical trials and drug labels, no unreported signals were identified. This finding will provide clinicians with a more comprehensive understanding of the clinical application of zanubrutinib and provide valuable insights for future investigations.