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<p>The FDA has approved pralsetinib as a chemotherapeutic drug for the treatment of individuals with cancers such as medullary thyroid cancer (MTC), papillary thyroid cancer (PTC), and non-small cell lung cancer (NSCLC). However, there is a lack of information on drug safety in large cohorts. Using data from the FDA Adverse Event Reporting System (FAERS) database, the aim of this study was to investigate the adverse events (AEs) linked to pralsetinib. All pralsetinib data reported from Q3 2020 to Q1 2023 were obtained from FAERS. The data was filtered and the AEs signals were found using Reporting Ratio Ratio (ROR), Proportionate Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma-Poisson Shrinker (MGPS). SAS 9.4 software was used for statistical analysis. A total of 802 reports, including 2733 AEs, were obtained using pralsetinib as the target drug. Interestingly, we identified seven new AEs that were not explicitly documented in the specification: Myocardial necrosis marker increased, Blood calcitonin increased, Troponin increased, Balance disorder, Cognitive disorder, Pulmonary embolism and Pneumothorax. The majority of pralsetinib-related AEs occurred within the first month after initiating treatment. Our findings concur with findings from earlier clinical and real-world investigations. New and unexpected signals of AEs with pralsetinib were also identified. For pralsetinib to be used as effectively as possible, prospective trials are required, and the drug’s long-term safety should be regularly checked.</p>

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Real-world FAERS safety analysis of Pralsetinib

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月27日

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  • Dongdong Zhang,
  • Yixin Sun,
  • Ying Cai,
  • Peiji Zeng,
  • Yue Wang,
  • Ming Cai,
  • Chengfu Cai

摘要

The FDA has approved pralsetinib as a chemotherapeutic drug for the treatment of individuals with cancers such as medullary thyroid cancer (MTC), papillary thyroid cancer (PTC), and non-small cell lung cancer (NSCLC). However, there is a lack of information on drug safety in large cohorts. Using data from the FDA Adverse Event Reporting System (FAERS) database, the aim of this study was to investigate the adverse events (AEs) linked to pralsetinib. All pralsetinib data reported from Q3 2020 to Q1 2023 were obtained from FAERS. The data was filtered and the AEs signals were found using Reporting Ratio Ratio (ROR), Proportionate Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma-Poisson Shrinker (MGPS). SAS 9.4 software was used for statistical analysis. A total of 802 reports, including 2733 AEs, were obtained using pralsetinib as the target drug. Interestingly, we identified seven new AEs that were not explicitly documented in the specification: Myocardial necrosis marker increased, Blood calcitonin increased, Troponin increased, Balance disorder, Cognitive disorder, Pulmonary embolism and Pneumothorax. The majority of pralsetinib-related AEs occurred within the first month after initiating treatment. Our findings concur with findings from earlier clinical and real-world investigations. New and unexpected signals of AEs with pralsetinib were also identified. For pralsetinib to be used as effectively as possible, prospective trials are required, and the drug’s long-term safety should be regularly checked.