New trial evidence has shown that Kite’s CAR-T cell therapy Yescarta (axicabtagene ciloleucel: axi-cel) reduces the risk of death by 27.4% in patients with relapsed or refractory large B-cell lymphoma (R/R LBCL), corresponding to a 38% improvement in overall survival (OS).
It is the only treatment in nearly 30 years to show statistically significant OS, with a median follow-up of 47.2 months.
The European Medicines Agency has approved a Type II variation to the Yescarta (axicabtagene ciloleucel) Summary of Product Characteristics (SmPC) to include these results.
The Phase III ZUMA-7 study axicabtagene ciloleucel treatment, within 12 months completion of first-line therapy, was compared with standard of care (SOC) as initial treatment in the curative setting for patients with R/R LBCL.
“Axicatagene ciloleucel is the first treatment in nearly three decades to significantly improve survival for patients with relapsed/refractory large B-cell lymphoma,” said Warner Biddle, Senior Vice President and Global Head of Commercial, Kite. “Overall survival is the gold standard in cancer treatment and these results were delivered despite over half of the trial participants in the standard of care arm receiving subsequent cellular immunotherapy. This update to the European label will provide clinicians with further confidence in the curative potential of axicabtagene ciloleucel.”
A type II variation is a change to the marketing authorisation of a treatment that may have a significant impact on the quality, safety or efficacy of a medicine, but does not involve a change to the active substance, its strength or the route of administration. Type II variations require formal approval by the European Medicines Agency.