Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database.

ABSTRACT:

Introduction

As chimeric antigen receptor T-cell therapies are becoming increasingly available in the armamentarium of the hematologist, there is an emerging need to monitor post-marketing safety.

Objective

We aimed to better characterize their safety profile by focusing on cytokine release syndrome and identifying emerging signals.

Methods

We queried the US Food and Drug Administration Adverse Event Reporting System (October 2017-September 2020) to analyze suspected adverse drug reactions to tisagenlecleucel (tisa-cel) and axicabtagene ciloleucel (axi-cel). Disproportionality analyses (reporting odds ratio) were performed by comparing chimeric antigen receptor T-cell therapies with (a) all other drugs (reference group 1) and (b) other onco-hematological drugs with a

SUBMITTER: Fusaroli M 

PROVIDER: S-EPMC9360149 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature