Skip to Main Content

Advertisement intended for health care professionals

Skip Nav Destination

Tisagenlecleucel Approved for R/R FL

August 30, 2022

September 2022

The U.S. Food and Drug Administration (FDA) granted accelerated approval of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy, for adult patients with relapsed/refractory (R/R) follicular lymphoma (FL). Use is permitted after two or more lines of prior therapy.

Tisagenlecleucel is FDA-approved in two other indications: pediatric and young adult B-cell acute lymphoblastic leukemia and adult R/R diffuse large B-cell lymphoma.

The FDA’s approval was granted based on the results of the phase II ELARA trial. During the study, prolonged durable response to treatment was demonstrated, with an estimated 85% of patients who achieved a complete response still in response 12 months later.

“Patients with FL who relapse or don’t respond to treatment have a poor prognosis and may face a series of treatment options without a meaningful, lasting response,” said institutional principal investigator Stephen J. Schuster, MD, of the University of Pennsylvania’s Abramson Cancer Center. “This new, effective option for patients with FL may offer long-term benefit.”

Side effects reported during the trial included cytokine release syndrome (CRS) in 53% of patients with no high-grade (>3) CRS cases and neurological events in 43% of patients with cases of high-grade neurological events in 6% of patients.

In early May 2022, the European Commission approved the drug for the treatment of adult patients with R/R FL after two or more lines of systemic therapy, the third indication for which this therapy is available to patients in the European Union.

Source: Novartis, May 28, 2022

Advertisement intended for health care professionals

Connect with us:

CURRENT ISSUE
October 2024

Advertisement intended for health care professionals

Close Modal

or Create an Account

Close Modal
Close Modal

Advertisement intended for health care professionals