APPROVALS

The approval is based on results from a phase 3 ZUMA-7 trial, the largest and longest Chimeric Antigen Receptor (CAR) T cell therapy versus standard of care (SOC) study in this patient population.

Yescarta is now the first CAR T cell therapy approved for patients in Europe who don’t respond to first-line treatment.

Typically, 60% of newly diagnosed large B cell lymphoma (LBCL) patients, including those with diffuse large B cell lymphoma (DLBCL), will respond favourably to initial treatment, however the remainder will either have no reaction, or relapse. Yescarta will be used to treat patients with DLBCL and high-grade B cell lymphoma (HGBCL), who relapse within 12 months or who don’t react to chemo-immunotherapy.

Christi Shaw, CEO, Kite stated: “We are very proud to announce Kite’s fifth approved indication in Europe in our continued commitment to the research and delivery of cell therapies with curative potential to patients who might benefit around the world. Today’s approval marks an important step by providing patients in Europe this option of CAR T cell therapy earlier in their treatment journey.”

Professor John Gribben, Professor of Medical Oncology at the Cancer Research UK Barts Centre, London, added, “This approval marks a major shift in the treatment of LBCL when initial treatment has failed. In ZUMA-7, treatment with axicabtagene ciloleucel resulted in an overall better outcome for patients than standard of care, especially in terms of event-free survival, marking a new era for treatment earlier in the disease pathway for more patients. The ZUMA-7 data has also broadened our understanding of this CAR T cell therapy, allowing us to better manage or prevent side effects, which is important as it moves earlier in the treatment pathway and for older patients and those with medical conditions for whom the standard of care might have been difficult.”