Research & Development
Kite's CAR T-cell Therapy Yescarta Receives Positive CHMP Opinion for Use in Second-line Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma
16 September 2022 - - The European Medicines Agency Committee for Medicinal Products for Human Use has issued a positive opinion for Yescarta (axicabtagene ciloleucel) for adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy, US-based biopharmaceutical company Kite, a Gilead Company (NASDAQ: GILD) said.

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