FDA Approves Label Update For Kite's Yescarta CAR T-Cell Therapy To Include Overall Survival Data

(RTTNews) - Kite, a Gilead Company (GILD), said that the U.S. Food and Drug Administration has approved a label update for Yescarta or axicabtagene ciloleucel to include the overall survival primary analysis from the landmark Phase 3 ZUMA-7 study. The analysis showed a statistically significant improvement for Yescarta in overall survival versus standard of care as second-line treatment with curative intent for patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) within 12 months of completion of first-line therapy.

The label update was based on results from the ZUMA-7 study which demonstrated a 27.4% reduction in the risk of death with Yescarta versus standard of care, a relative 38% improvement in overall survival. With an estimated median follow up of 46.7 months overall, the primary analysis of overall survival showed a statistically significant improvement in the Yescarta arm compared to the standard therapy arm, despite more than half of patients (57%) in the standard of care arm subsequently receiving cell therapy off protocol. The estimated 39-month overall survival rates were 55.9% in the Yescarta arm and 46% in the standard of care arm.

In November 2023, the European Medicines Agency approved an update to the Summary of Product Characteristics to include the ZUMA-7 overall survival analysis.

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