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Published on: September 30, 2019
Data mining and safety analysis of FGFR tyrosine kinase inhibitors based on the FAERS database
Ping Li1, Liming Wu2, Zhihui Song3
1Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Abstract:
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.
Insights
Real-world data reveal new safety concerns for fibroblast growth factor receptor tyrosine kinase inhibitors (FGFR-TKIs) like erdafitinib, pemigatinib, and futibatinib. This analysis highlights previously unidentified adverse events and risks in specific patient groups.
Area of Science:
- Oncology
- Pharmacovigilance
- Drug Safety
Background:
- Fibroblast growth factor receptor tyrosine kinase inhibitors (FGFR-TKIs) show promise for FGFR-driven cancers.
- Clinical trial efficacy is established, but real-world safety data for FGFR-TKIs are limited.
Purpose of the Study:
- To evaluate the real-world safety profiles of FGFR-TKIs (erdafitinib, pemigatinib, futibatinib).
- To identify novel adverse events (AEs) and safety patterns beyond clinical trial data.
Main Methods:
- Utilized post-marketing data from the FDA Adverse Event Reporting System (FAERS) from Q2 2019 to Q3 2024.
- Employed disproportionality analysis to assess AE frequencies and time-to-onset.
- Conducted subgroup analysis for specific patient demographics.
Main Results:
- Analyzed 1,629 reports; common AEs included general, gastrointestinal, and skin/subcutaneous tissue disorders.
- Identified novel AEs: corneal thinning (erdafitinib), reduced fluid intake (pemigatinib), decreased blood magnesium (futibatinib).
- Observed delayed AE onset for erdafitinib (56.5 days) vs. pemigatinib (29 days) and futibatinib (25 days); futibatinib showed increased mortality risk in patients <65 years.
Conclusions:
- Real-world data reveal emerging safety concerns for FGFR-TKIs not seen in clinical trials.
- Findings provide crucial safety information for oncologists managing patients on FGFR-TKIs.
- Highlights the importance of post-marketing surveillance for comprehensive drug safety assessment.
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