Comprehensive safety assessment of ribociclib: A real-world analysis using the FDA Adverse Event Reporting System (FAERS) database.

Aims: Ribociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that was approved by the US Food and Drug Administration (FDA) in 2017 for the treatment of advanced hormone receptor-positive (HR+) breast cancer. The presented study aimed to evaluate the ribociclib-associated adverse events (AEs) through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods: Data were collected from the FAERS database covering the period from the first quarter of 2017 to the first quarter of 2023. Disproportionality analyses were employed to quantify the associated AE signals of ribociclib and detect the risk signals using reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the empirical Bayes geometric mean (EBGM), and MedDRA was used to systematically classify the results.

Results: A total of 9533 AE reports of ribociclib were obtained using data from the FAERS database, and ribociclib-associated AEs targeted 23 system organ classes (SOCs) after conforming to the four algorithms simultaneously. The common significant SOCs were identified, including benign, malignant and unspecified neoplasms, immune system disorders, etc. The significant AE signals were then mapped to preferred terms (PTs), associated with tumorigenesis and haematologic toxicity, which have emerged in the study, usually reported in patients with ribociclib. Of note, unexpected significant AEs, including "left atrial enlargement", "erysipelas", "polyneuropathy", "glomerular filtration rate decreased", "ageusia", and so on, were uncovered in the label.

Conclusions: Our study provides real-world safety data on post-marketing surveillance and highlights potential new and unexpected AE signals during ribociclib treatment.