Yescarta approved for second-line LBCL in China

Yescarta, the first approved CAR T-cell therapy in China, recently received approval of a new indication of adults with large B-cell lymphoma who have failed first-line immunochemotherapy or relapsed within 12 months after first-line immunochemotherapy (r/r LBCL).

The approval was based on the ZUMA-7 study, in which Yescarta demonstrated that at a median follow-up of two years, patients 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<0.001) over the current SOC (8.3 months vs 2.0 months).

Additionally, Yescarta demonstrated a 2.5 fold increase in patients who were alive at two years without disease progression or need for additional cancer treatment vs SOC (41% v 16%).

At the American Society of Clinical Oncology (ASCO) earlier this month, it was revealed that Yescarta significantly improved the overall survival (OS) of patients (median OS not reached vs. 31.1 months), and the risk of death of patients was reduced by 27.4%. The estimated 4-year OS rate of the trial group was 54.6% (vs. 46.0%), the median progression-free survival (PFS) was better (14.7 months vs. 3.7 months), and the 4-year PFS rate was 41.8% (vs. 24.4%).

Yescarta was first approved in China in June 2021 for the treatment of adult patients with relapsed or refractory (R/R) LBCL after two or more lines of systemic therapy. The CAR-T therapy from Gilead and Fosun Kite was the first to be approved for use in China. 

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