Osimertinib-Induced Cardiotoxicity: A Retrospective Review of the FDA Adverse Events Reporting System (FAERS).

ABSTRACT:

Objectives

The goal of this study was to compare the risk of cardiotoxicity with osimertinib versus all other drugs and versus epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) (erlotinib, afatinib, and gefitinib) in the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS), a pharmacovigilance database.

Background

Osimertinib has been shown to improve outcomes in T790M-positive non-small cell lung cancer patients who progress on EGFR-TKI therapy and in the frontline setting in EGFR mutated non-small cell lung cancer. In pivotal trials, osimertinib was associated with higher rates of cardiotoxicity compared with the control arm.

Methods

FAERS was queried for "Cardiac failure," "Electrocardiogram QT-prolonged," "Atrial Fibril

SUBMITTER: Anand K 

PROVIDER: S-EPMC8352117 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature