Gilead's Kite Files US Application To Expand Use Of Yescarta In Second-Line Setting
- Kite Pharma, a Gilead Science Inc Company (NASDAQ: GILD), has submitted a supplemental marketing application to the FDA for Yescarta (axicabtagene ciloleucel).
- The application seeks to expand Yescarta's current indication to include adults with relapsed or refractory large B-cell lymphoma (LBCL) in the second-line setting.
- The filing is based on data from the ZUMA-7 study with a follow-up of over two years.
- The study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398), representing a clinically meaningful 60% reduction in risk of EFS events versus standard of care.
- The interim analysis of overall survival (OS) showed a trend favoring Yescarta; however, the data are immature at this time, and further analyses are planned for the future.
- Detailed results from ZUMA-7 have been submitted for presentation at an upcoming medical congress.
- Related content: Benzinga's Full FDA Calendar.
- Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for relapsed or refractory LBCL after two or more lines of systemic therapy.
- Price Action: GILD stock traded 1.50% lower at $68.80 premarket on the last check Friday.
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Posted-In: Briefs lymphomaBiotech News Health Care FDA General
