BRIEF—EMA approves Type II variation for Yescarta

The European Medicines Agency has approved a Type II variation to the Yescarta (axicabtagene ciloleucel) Summary of Product Characteristics (SmPC) to include the overall survival (OS) analysis of the landmark Phase III, Gilead Sciences’ Kite subsidiary announced today.

The ZUMA-7 study, in which axicabtagene ciloleucel treatment, within 12 months completion of first-line therapy, was compared with standard of care (SOC) as initial treatment in the curative setting for patients with relapsed or refractory large B-cell lymphoma (R/R LBCL).

Yescarta generated third-quarter 2023 sales of $391 million, up 23% year-on-year.

Further supporting data for the EMA approval included from the primary OS analysis, conducted per protocol five years after the first subject was randomized, demonstrated a statistically-significant improvement in OS with axicabtagene ciloleucel versus SOC.

The estimated 48-month OS rates were 54.6% for axicabtagene ciloleucel versus 46.0% in the SOC arm, with a 27.4% reduction in the risk of death, which corresponds to a 38% relative improvement in overall survival.