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Data mining and safety analysis of FGFR tyrosine kinase inhibitors based on the FAERS database

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收录情况： ◇ SCIE

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机构： [1]Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University, Beijing, China. [2]Department of Urology, Nanjing Drum Tower Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.

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关键词： FGFR-TKIs FAERS Disproportionality analysis Drug safety Adverse events

摘要：

Fibroblast growth factor receptor tyrosine kinase inhibitors (FGFR-TKIs), including erdafitinib, pemigatinib, and futibatinib, are a promising class of therapies for FGFR-driven cancers. While their efficacy is established in clinical trials, real-world safety data remain limited. This study leveraged post-marketing data from the FDA Adverse Event Reporting System (FAERS) between the second quarter of 2019 and the third quarter of 2024 to evaluate the safety profiles of FGFR-TKIs through disproportionality analysis. A total of 1,629 reports were included (erdafitinib: 982, pemigatinib: 558, futibatinib: 89). The most frequently reported adverse events (AEs) belonged to general disorders, gastrointestinal disorders, and skin and subcutaneous tissue disorders. Notably, several novel AEs not previously identified in clinical trials or drug labels were detected, including corneal thinning associated with erdafitinib, fluid intake reduced with pemigatinib, and blood magnesium decreased with futibatinib. Time-to-onset analysis revealed that delayed median AE onset for erdafitinib (56.5 days) compared to pemigatinib (29 days) and futibatinib (25 days), although all exhibited early failure-type patterns. Subgroup analysis indicated an increased risk of death in futibatinib-treated patients aged < 65 years. These findings offer critical insights beyond clinical trials, informing oncologists of emerging safety concerns associated with FGFR-TKIs in real-world settings.© 2025. The Author(s).

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出版当年[2025]版：

大类 | 3 区综合性期刊

小类 | 3 区综合性期刊

最新[2025]版：

大类 | 3 区综合性期刊

小类 | 3 区综合性期刊

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出版当年[2023]版：

Q1 MULTIDISCIPLINARY SCIENCES

最新[2024]版：

Q1 MULTIDISCIPLINARY SCIENCES

影响因子： 3.9 最新[2024版] 4.3 最新五年平均 3.8 出版当年[2023版] 4.3 出版当年五年平均 4.6 出版前一年[2022版] 3.9 出版后一年[2024版]

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第一作者机构： [1]Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University, Beijing, China.

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