Post-marketing safety of pralsetinib: a real-world disproportionality analysis based on the FDA adverse event reporting system database.
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BACKGROUND: Pralsetinib is a novel rearranged during transfection (RET) inhibitor that is approved for treating non-small cell lung cancer and thyroid cancer. Although clinical trials have established its efficacy, real-world data on its safety profile remain limited. AIM: This study aimed to analyze pralsetinib-related adverse events (AEs) reported in the Food and Drug Administration adverse event reporting system (FAERS) database to identify potential safety signals. METHOD: We conducted a retrospective pharmacovigilance analysis using FAERS database from Q3 2020 to Q2 2024. After deduplication, disproportionality analysis was performed using four algorithms: reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and empirical Bayes geometric mean. RESULTS: A total of 1064 pralsetinib-related reports were identified, encompassing 3608 AEs. The most common AEs were hypertension (n = 80), asthenia (n = 79), anemia (n = 65), white blood cell count decreased (n = 63), and constipation (n = 58). We also detected new and unexpected AE signals, including blood calcitonin increased (ROR: 853.54), myocardial necrosis marker increased (ROR: 201.79), cystitis bacterial (ROR: 134.84), fungal foot infection (ROR: 51.83), pulmonary tuberculosis (ROR: 39.5), and myocardial injury (ROR: 30.36). Additionally, hypertension was more prevalent among female patients (Female/Male = 53/19, ROR: 1.8 [1.06-3.05]) and olderpatients (≥ 65/ < 65 = 34/18, ROR: 1.8 [1.01-3.2]). CONCLUSION: Our study identified some known and new significant AE signals associated with pralsetinib, emphasizing the importance of continued pharmacovigilance. While the findings provide valuable insights for clinical practice, further validation through large-scale prospective studies is needed.