Abstract
OBJECTIVE: Pluvicto(®) (Lutetium-177-PSMA-617) was the world's first radiolabeled drug for the treatment of metastatic castration-resistant prostate cancer that was positive for prostate-specific membrane antigen with limited global use to date. Our study aimed to conduct a thorough analysis based on the Adverse Event (AE) reporting system FAERS of the Food and Drug Administration (FDA), providing insights for its future clinical application. METHODS: The AEs reports suspected primarily of Pluvicto(®) from April 1, 2022, to December 31, 2024, were retrieved from the FAERS system to conduct a disproportionality test. The characteristics of these reports were analyzed including demographic features, time of AE occurrence, and features of AEs. AEs were classified by System Organ Classes (SOCs) and preferred terms (PTs) according to the Medical Dictionary for Regulatory Activities (MedDRA(®)). The disproportionality of results was analyzed by Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). RESULTS: A total of 7654 patient reports primarily suspected of Pluvicto(®) were submitted to the database, demonstrating a monthly increasing trend in reporting frequency. Demographic analysis revealed 85 records with weights ≥ 90 kg (24.3%). 649 Preferred Terms (PTs) were identified, and after screening, from which 33 significant PT signals meeting all four pharmacovigilance algorithms (ROR, PRR, BCPNN, and MGPS) were detected, which were subsequently classified into 10 System Organ Classes (SOCs), in which 15 significant AE signals correlated with drug effect were obtained. Most cases occurring within the first 3 months after Pluvicto(®) treatment. Timetoevent profiling demonstrated significant differences, with Nervous system disorders showed distinct early-onset pattern within first 10 days. In addition to hematologic AEs, consistent high signals were observed for AEs such as dry mouth, laboratory test abnormal, and general physical health deterioration. CONCLUSIONS: The study confirmed many significant AE signals that have been listed in the prescribing information or reported in previous studies. Special attention should be paid to patients over 90Kg. It was recommended that intensified laboratory screening of clinical indexes, implement early neurologic monitoring.