A real-world pharmacovigilance study of FDA adverse event reporting system events for Lutetium-177-PSMA-617

Lutetium-177(¹⁷⁷Lu)-PSMA-617 has been approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Our main objective is to elucidate the association between ¹⁷⁷Lu-PSMA-617 and reported adverse events (AEs) in the FDA Adverse Event Reporting System (FAERS) database. Relevant information regarding ¹⁷⁷Lu-PSMA-617 usage and reports of AEs was extracted from the FAERS database. The Empirical Bayes Geometric Mean (EBGM), Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and Bayesian Confidence Propagation Neural Network (BCPNN) with their 95% confidence intervals (CI) were calculated using four algorithms of disproportionality analysis. The pharmacovigilance signals deemed significant across the four algorithms were considered associated with drug use. We collected 6266 unique reports related to ¹⁷⁷Lu-PSMA-617 usage from the FAERS database. Compared to other drugs, ¹⁷⁷Lu-PSMA-617 usage was associated with a higher risk of anemia, platelet count decreased, and pancytopenia. In addition to hematologic AEs, consistent high signals were observed for AEs such as dry mouth, laboratory test abnormal, and general physical health deterioration. The analysis based on mCRPC treatment drugs showed that full blood count decreased, general physical health deterioration, and laboratory test abnormal continued to exhibit significant signals. Furthermore, the number of AEs reports for ¹⁷⁷Lu-PSMA-617 decreased over time, with most reports occurring within one month after drug administration. Our study compiled AEs associated with ¹⁷⁷Lu-PSMA-617 in real-world drug usage and highlighted its propensity for specific AEs in the context of mCRPC treatment. These findings will contribute to enhancing our clinical experience with this medication.