If approved, Yescarta will be the first Chimeric Antigen Receptor T-cell therapy approved for patients in Europe who do not respond to first-line treatment.
Although 60% of newly diagnosed LBCL patients will respond to their initial treatment, 40% will relapse or will not respond and need 2nd line treatment.
The European Commission will review the CHMP opinion, and a final decision on the marketing authorization is expected in the coming months.
The positive opinion for Yescarta is based on the primary results of the landmark Phase 3 ZUMA-7 study, the largest and longest trial of a CAR T-cell therapy versus standard of care in second-line LBCL.
Results demonstrated that at a median follow-up of two years, Yescarta-treated 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
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