Post-marketing safety of lorlatinib: a real-world study based on the FDA adverse event reporting system
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View abstract on PubMed
Summary
This summary is machine-generated.This study analyzed 2,941 adverse event reports for lorlatinib, identifying common side effects like high cholesterol and edema. It also flagged potential new risks, including pulmonary arterial hypertension, for anaplastic lymphoma kinase-positive non-small cell lung cancer patients.
Area Of Science
- Oncology
- Pharmacovigilance
- Clinical Pharmacology
Background
- Lorlatinib demonstrates significant efficacy in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
- Establishing the post-marketing safety profile of lorlatinib is crucial for clinical practice.
Purpose Of The Study
- To determine the safety profile of lorlatinib using the Food and Drug Administration Adverse Event Reporting System (FAERS).
- To identify potential adverse events (AEs) associated with lorlatinib through disproportionality analysis.
Main Methods
- A disproportionality analysis was conducted on FAERS data from 2019 to 2023.
- Reporting Odds Ratio (ROR) was used to detect lorlatinib-related AEs.
- Clinical characteristics, demographics, and time to onset of AEs were investigated.
Main Results
- 2,941 lorlatinib-associated AE reports were identified out of 8,818,870 total reports.
- 167 lorlatinib-related AE signals were detected, with hypercholesterolemia, edema, and cognitive disorders being frequent.
- New potential AEs such as pulmonary arterial hypertension and radiation necrosis require further attention, alongside evaluation of interstitial lung disease and AV block.
Conclusions
- The study offers insights into lorlatinib's post-marketing safety, aiding rational clinical use.
- Further prospective studies are recommended to validate the identified lorlatinib-AE associations.
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