EC Grants Marketing Authorization to Axicabtagene Ciloleucel for Use in Second-Line DLBCL, HGBL

The European Commission (EC) has granted marketing authorization to axicabtagene ciloleucel for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

The approval is based on results from ZUMA-7, an ongoing, randomized, open-label, phase III study of 359 patients at 77 international centers evaluating the safety and efficacy of a single infusion of axicabtagene ciloleucel versus current standard of care (SOC) for second-line therapy in adult patients with relapsed or refractory LBCL within 12 months of first-line therapy.

The ZUMA-7 study demonstrated that at a median follow-up of two years, patients treated with axicabtagene ciloleucel had a four-fold greater improvement in the primary endpoint of event-free survival (EFS; hazard ratio, 0.40; 95% CI, 0.31-0.51, P<.001) over the current SOC (8.3 months vs 2.0 months).

Axicabtagene ciloleucel also demonstrated a 2.5-fold increase in patients who were alive at two years without disease progression or need for additional cancer treatment versus SOC (41% vs 16%).

Improvements in EFS with axicabtagene ciloleucel were consistent across key patient subgroups, including elderly patients (HR, 0.28; 95% CI, 0.16-0.46), primary refractory patients (HR, 0.43; 95% CI, 0.32- 0.57), HGBL patients (HR, 0.28; 95% CI, 0.14-0.59), and double-expressor lymphoma patients (HR, 0.42; 95% CI, 0.27-0.67).

Source: BusinessWire, October 2022