The European Union (EU) has granted market authorization to axicabtagene ciloleucel as a second-line therapy for adult patients with B-cell lymphoma. Axicabtagene ciloleucel is a CAR-T therapy that is produced by Kite, a division of Gilead Sciences. It is marketed under the name Yescarta.
Immunotherapy is at the forefront of treatment approaches for cancer patients. In addition to first-line therapy, immune-based treatments are also considered for second-line treatment. Axicabtagene ciloleucel has acquired approval and marketing authorization in Europe for treating patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) who relapse within a year or are refractory to, first-line chemoimmunotherapy. The European decision follows American approval earlier this year.
The authorizations are based on the findings of the Phase-III ZUMA study. The randomized study evaluated the efficacy of axicabtagene ciloleucel for treating patients with early relapsed or refractory LBCL after first-line of chemotherapy. The patients that were treated with axicabtagene ciloleucel had a fourfold improvement in event-free survival versus the current standard of care (SOC) (8.3 vs 2months). Further, more than twice the patients treated the medicine were alive for at least two years without disease progression as compared to those treated with SOC (16%). Notably, the clinical benefits associated with axicabtagene ciloleucel were consistent across disease subgroups such as elderly, primary refractory patients, high-grade B-cell lymphoma and double-expressor lymphoma patients.
The therapy was granted a positive opinion by European Medicines Agency’s Committee for Medicinal Products for Human Use last month.