European Commission grants approval of axicabtagene ciloleucel for the treatment of adult patients with R/R DLBCL and HGBL

On October 17, 2022, it was announced that axicabtagene ciloleucel (axi-cel) received marketing authorization by the European Commission for the treatment of adult patients with diffuse large B-cell lymphoma and high-grade B-cell lymphoma who relapse within 12 months of, or are refractory to, first-line chemotherapy.¹

This decision is based on data from the landmark ZUMA-7 trial (NCT03391466). Axi-cel demonstrated a 4-fold improvement in event-free survival (8.3 months vs 2 months) at the median 2-year follow-up, a 2.5-fold increase in 2-year event-free survival rates (41% vs 16%) compared with current standard of care (SOC) regimens, and a manageable safety profile.¹

In the patient reported outcomes analysis, recently reported on the Lymphoma Hub, axi-cel showed statistically significant and clinically meaningful improvements over SOC by Day 100 for specific quality of life measures. Given the therapeutic benefit of axi-cel over SOC, its approval by the European Commission marks a positive treatment advancement for patients with relapsed/refractory large B-cell lymphoma.