Gilead Sciences company Kite has secured approval from the European Commission (EC) for Yescarta (axicabtagene ciloleucel) to treat adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).
The approval was granted based on data obtained from the pivotal Phase III ZUMA-7 study, which is said to be the largest and longest trial of a Chimeric Antigen Receptor (CAR) T-cell therapy against the standard of care (SOC) in this patient population.
ZUMA-7 is an ongoing, randomised, open-label, global and multicentre Phase III study that is assessing the safety and efficacy of a single infusion of Yescarta against current SOC for second-line therapy in adult patients with relapsed or refractory LBCL within 12 months of first-line therapy.
Event-free survival (EFS) is the primary endpoint of the trial, while objective response rate (ORR) and overall survival (OS) are the key secondary endpoints. Patient-reported outcomes and safety are additional secondary endpoints.
According to Gilead, patients receiving Yescarta demonstrated statistically significant improvements in Quality of Life (QoL) at Day 100 as against those who received SOC in the analysis of patient-reported outcomes (PROs).
Kite CEO Christi Shaw said: “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.”
Yescarta is claimed to be the first CAR T-cell therapy approved for patients in Europe who do not respond to first-line treatment.
First approved in Europe in 2018, it is presently used to treat five types of blood cancers, including large B-Cell lymphoma (LBCL), primary mediastinal large B-Cell lymphoma (PMBCL), and follicular lymphoma (FL) besides DLBCL and HGBL.