Postmarketing Safety of Sacituzumab Govitecan: A Pharmacovigilance Study Based on the FDA Adverse Event Reporting System

Abstract

Sacituzumab govitecan is widely used for the treatment of breast cancer and urothelial carcinoma, but available information regarding adverse events (AEs) is limited. We aim to explore the AE induced by sacituzumab govitecan by mining the FDA Adverse Event Reporting System (FAERS) database. The association between sacituzumab govitecan and AEs was evaluated using the information component. A multivariate logistic regression analysis was conducted for all identified signals to explore the risk factors associated with AEs leading to hospitalization. In total, 1,884 reports related to sacituzumab govitecan were retrieved, and 114 AE signals involving 20 systems were identified. The median time for onset of AEs was ~ 6-7 days after initiating treatment with sacituzumab govitecan, with over 80% of AEs occurring within 30 days. Subgroup analysis revealed that 14 signals were reported in men and 110 in women. There were 58 signals reported in patients under 65 following the use of sacituzumab govitecan, 59 signals in patients over 65, and 31 signals were present in both groups. Multivariable analysis showed that being male and the occurrence of colitis, pneumonitis, febrile neutropenia, pyrexia, sepsis, dehydration, and diarrhea were risk factors leading to hospitalization with an area under the curve (AUC) of 0.89. Additionally, sensitivity analysis revealed that this study had good robustness. This is the first retrospective analysis based on FAERS to review the safety of sacituzumab govitecan. The results highlight the need to closely monitor adverse reactions such as neutropenia, diarrhea, colitis, and sepsis when using sacituzumab govitecan.