Yescarta nears new indication after LBCL data

Gilead Sciences’ (Nasdaq: GILD) subsidiary Kite has announced top-line results from the primary analysis of ZUMA-7, a global Phase III study showing superiority of Yescarta (axicabtagene ciloleucel) compared to standard of care (SOC) in second-line relapsed or refractory large B-cell lymphoma (LBCL).

Based on these findings, Kite will submit a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) to expand the indication for Yescarta to more patients, earlier in their disease. If approved, this would be a first for CAR-T.

"A potential paradigm shift in the treatment of LBCL"With a median follow-up of two years, the ZUMA-7 study met the primary endpoint of event-free survival. The trial also met the key secondary endpoint of objective response rate.