The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the European Commission approve tisagenlecleucel (Kymriah), a CAR-T cell therapy, for the treatments of adults with relapsed or refractory follicular lymphoma who have had two or more prior lines of therapy.
The opinion was based on data from the phase 2 ELARA trial that included 94 patients infused with the product. Among those treated with tisagenlecleucel, 86% responded; 69% had a complete response. Importantly, a prolonged durable response was seen with about 87% of patients who had a complete response still in response nine months after initial response.
Safety outcomes were “remarkable”. Although about one-half of patients experience cytokine release syndrome (CRS), there were no grade 3 or higher cases. Grade 3 or 4 neurological events occurred in 3% of patients within eight weeks of infusion.
This positive opinion from the CHMP could pave the way for a third indication for tisagenlecleucel in the EU. It is also approved for pediatric and young adult patients aged 25 and younger with B cell acute lymphoblastic leukemia that is refractory, in relapse posttransplant, or in second or later relapse, and in adult patients with relapsed/refractory diffuse large B cell lymphoma who have had two or more prior lines of therapy.
A final decision is expected in about two months.
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