FDA approves label update for Yescarta CAR T-Cell therapy to include overall survival data for patients with relapsed or refractory large B-cell lymphoma .- Kite/Gilead
Kite, a Gilead Company announced that the FDA has approved a label update for Yescarta (axicabtagene ciloleucel) to include the overall survival (OS) primary analysis from the landmark Phase III ZUMA-7 study showing a statistically significant improvement for Yescarta in OS versus standard of care (SOC) as second-line treatment with curative intent for V(R/R LBCL) within 12 months of completion of first-line therapy.
The label update is based on results from the ZUMA-7 study which demonstrated a 27.4% reduction in the risk of death with Yescarta versus SOC, a relative 38% improvement in OS. With an estimated median follow up of 46.7 months overall, the primary analysis of OS showed a statistically significant improvement in the Yescarta arm compared to the standard therapy arm, despite more than half of patients (57%) in the SOC arm subsequently receiving cell therapy off protocol. The estimated 39-month OS rates were 55.9% in the Yescarta arm and 46% in the SOC arm.
“This U.S. label update for Yescarta is an important step to reinforce healthcare provider confidence to treat eligible patients with Yescarta, immediately following progression or relapse in large B-cell lymphoma,” said Frank Neumann, MD, PhD, Senior Vice President and Global Head of Clinical Development, Kite. “Our ZUMA-7 overall survival analysis proves that when given as second-line therapy, Yescarta is even more effective in improving patient survival than standard of care treatment. Coupled with our rapid and reliable manufacturing, it is our hope to provide patients a chance to live longer lives.”
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