Tisagenlecleucel receives FDA approval for the treatment of relapsed or refractory follicular lymphoma

On May 28, 2022, it was announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for the use of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell product, for the treatment of adult patients with relapsed or refractory follicular lymphoma who have previously received ≥2 lines of systemic therapy.¹ To conform with the accelerated approval program, continued approval in this setting may be dependent upon verification and proven clinical benefit in a confirmatory trial(s). This approval marks the third indication that tisagenlecleucel has received FDA approval for, and it remains the only CAR T-cell therapy approved in both adult and pediatric settings. The approval is based on pivotal data obtained from the phase II ELARA trial (NCT03568461),¹ previously reported on the Lymphoma Hub.

Efficacy¹

• 86% overall response rate
• 68% complete response rate
• 85% of patients who achieved a complete response were still in response 12 months later

Safety¹

• 53% of patients experienced any-grade cytokine release syndrome (none were Grade 3/4)
• 43% of patients experienced any-grade neurologic events, with 6% being Grade 3/4
• 18% of patients were infused in an outpatient setting