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

On May 4, 2022, it was announced that the European Commission (EC) had approved the use of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell product, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who previously received ≥2 lines of systemic therapy. This is the third indication tisagenlecleucel has been approved for in the EU and the first CAR T-cell therapy approved for the treatment of FL, including patients with Grade 1, 2, and 3A relapsed or refractory FL.¹ The approval is based on key data obtained from the phase II ELARA trial (NCT03568461), previously reported on the Lymphoma Hub.

Of the 97 heavily pretreated patients who received tisagenlecleucel, 94 were evaluable for efficacy and 97 were evaluable for safety. The median follow-up time was approximately 21 months.

Efficacy

• 86% overall response rate
• 69% complete response rate
• 87% of patients who achieved a complete response were still in response at ≥9 months

Safety

• Cytokine release syndrome occurred in 50% of patients (none were Grade 3/4).
• Neurological adverse reactions were reported in 9% of patients (1% were Grade 3/4) within 8 weeks of infusion.
• Grade 3/4 severe infections occurred in 16% of patients.