NEW YORK – The European Commission on Tuesday approved Gilead Sciences' CAR T-cell therapy Yescarta (axicabtagene ciloleucel) for relapsed or refractory follicular lymphoma patients after three or more prior treatments.
European regulators based the decision on the results of the Phase II ZUMA-5 clinical trial, in which the overall response rate among 75 relapsed or refractory follicular lymphoma patients after three or more lines of therapy was 91 percent. After two years of follow-up, 77 percent of patients experienced a complete response. The median duration of response was 38.6 months, and after 24 months, 56 percent of patients were still in remission.
Last year, the US Food and Drug Administration approved the autologous CAR T-cell therapy as a third-line option for relapsed or refractory follicular lymphoma patients — an earlier setting given the European approval is in the fourth-line setting.
Both Novartis and Bristol Myers Squibb's competing anti-CD19 autologous CAR T-cell therapies, Kymriah (tisagenlecleucel) and Breyanzi (lisocabtagene maraleucel), have European approval as third-line treatments for follicular lymphoma, though with slightly different labels. Novartis' Kymriah is approved for previously treated, refractory patients with grade 1, 2, and 3A follicular lymphoma, while BMS's Breyanzi is approved for patients with grade 3B disease.