BRIEF—FDA updates label for Kite's Yescarta CAR T-cell therapy to include OS data

The US Food and Drug Administration (FDA) has approved a label update for Gilead Sciences subsidiary Kite’s Yescarta (axicabtagene ciloleucel).

The update will 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 patients with relapsed or refractory large B-cell lymphoma (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 armLabel,