Axi-cel receives positive CHMP opinion for the treatment of adult patients with DLBCL and high-grade BCL

On September 16, 2022, it was announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) had declared a positive opinion for axicabtagene ciloleucel (axi-cel) as a second-line therapy for adult patients with diffuse large B-cell lymphoma and high-grade B-cell lymphoma that is refractory to, or relapses within 12 months of, first-line chemotherapy. This announcement is based on key data obtained from the pivotal phase III ZUMA-7 trial (NCT03391466).¹

The ZUMA-7 trial reported superior event-free survival for axi-cel over the current standard of care (8.3 months vs 2 months). In addition, axi-cel demonstrated an increase in the number of patients who were alive at the 2-year mark, without disease progression or the need for further cancer treatment compared to standard of care (41% vs 16%), along with a favorable safety profile. These results were observed across multiple patient subgroups, including patients with high-grade B-cell lymphoma.