NEW YORK – The European Commission on Friday expanded approval of Bristol Myers Squibb's CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) as a third-line treatment for adult patients with relapsed or refractory follicular lymphoma.
The EC approved the indication based on results from the Phase II TRANSCEND FL study, in which BMS evaluated Breyanzi in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including follicular lymphoma. Around 97 percent of patients responded to the autologous CAR T-cell therapy and 94 percent had a complete response in the third-line or later patient subgroup. The median time to first response was under a month and 75.7 percent of patients were still responding at 18 months.
Novartis' CAR T-cell therapy Kymriah (tisagenlecleucel) is also approved in Europe as a third-line treatment for relapsed or refractory follicular lymphoma. Gilead Sciences' Yescarta (axicabtagene ciloleucel), meanwhile, is approved in Europe for follicular lymphoma patients after three or more prior treatments.
Last year, the US Food and Drug Administration approved Breyanzi in the same third-line setting for follicular lymphoma patients.
In Europe, Breyanzi was approved in 2022 as a third-line treatment and in 2023 as a second-line therapy for relapsed or refractory large B-cell lymphomas, including diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma.