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Updated: Jan 28, 2026
High Density Event-related Potential Data Acquisition in Cognitive Neuroscience
Published on: April 16, 2010
Neurological adverse events of ROS1 inhibitors for non-small cell lung cancer: data from the FDA adverse event
Xueying Wei1, Qianhui Lai1, Lingxiao Zheng2
1Department of Geriatrics, The Eighth Affiliated Hospital of Sun Yat-sen University, Shenzhen, Guangdong, China.
Background:
ROS1 inhibitors play a critical role in the treatment of ROS1 fusion-positive non-small cell lung cancer (NSCLC). Although agents such as Crizotinib, Ceritinib, Lorlatinib, Entrectinib, and Repotrectinib have demonstrated strong efficacy and intracranial activity, their neurological safety profiles remain insufficiently characterized in real-world settings. This study aimed to evaluate the neurological adverse events (AEs) of ROS1 inhibitors using the FDA Adverse Event Reporting System (FAERS) database.
Methods:
We conducted a pharmacovigilance analysis of FAERS reports from 2011Q4 to 2024Q4. Disproportionality analysis was used to detect potential AE signals, followed by time-to-onset and logistic regression analyses to assess the onset timing and mortality risk associated with neurological AEs.
Results:
A total of 7,296 AE reports related to ROS1 inhibitors were identified. Neurological AEs were prominent, with distinct patterns across drug generations. Common events included dysgeusia, dysarthria, cognitive disorder, and taste disturbance. Novel inhibitors such as Lorlatinib, Entrectinib, and Repotrectinib showed earlier onset of neurotoxicity, whereas older agents (Crizotinib and Ceritinib) were associated with delayed or cumulative neurological events. Despite stronger neurotoxicity signals, Entrectinib demonstrated a relatively favorable safety profile with fewer fatal outcomes.
Conclusion:
This study provides real-world evidence that newer ROS1 inhibitors exhibit earlier but generally manageable neurological AEs. Clinicians should implement early neurotoxicity monitoring and individualized risk assessment to ensure safe and effective targeted therapy for ROS1-positive NSCLC.
Insights
Newer ROS1 inhibitors for non-small cell lung cancer show earlier neurological side effects, but they are manageable. Early monitoring is key for safe and effective treatment of ROS1-positive NSCLC.
Area of Science:
- Oncology
- Pharmacovigilance
- Neurology
Background:
- ROS1 inhibitors are crucial for ROS1 fusion-positive non-small cell lung cancer (NSCLC).
- Real-world neurological safety data for these agents is limited.
- This study analyzes neurological adverse events (AEs) of ROS1 inhibitors using FAERS data.
Purpose of the Study:
- To evaluate the neurological safety profile of ROS1 inhibitors in real-world settings.
- To characterize the onset and risk of neurological AEs associated with different ROS1 inhibitors.
- To compare the neurological safety of novel versus older ROS1 inhibitor generations.
Main Methods:
- Pharmacovigilance analysis of FDA Adverse Event Reporting System (FAERS) data from 2011Q4 to 2024Q4.
- Disproportionality analysis to identify potential AE signals.
- Time-to-onset and logistic regression analyses for AE timing and mortality risk.
Main Results:
- 7,296 AE reports for ROS1 inhibitors were identified, with prominent neurological AEs.
- Common neurological AEs included dysgeusia, dysarthria, cognitive disorder, and taste disturbance.
- Novel inhibitors (Lorlatinib, Entrectinib, Repotrectinib) had earlier neurotoxicity onset; older agents (Crizotinib, Ceritinib) showed delayed/cumulative effects. Entrectinib had fewer fatal outcomes despite neurotoxicity signals.
Conclusions:
- Newer ROS1 inhibitors present earlier, generally manageable neurological AEs.
- Early neurotoxicity monitoring and individualized risk assessment are recommended for safe and effective treatment of ROS1-positive NSCLC.
- Real-world data supports informed clinical decision-making for targeted NSCLC therapy.
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