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# FDA Updates Kite Yescarta Label
- URL: https://www.fdaweb.com/fda-updates-kite-yescarta-label/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:19:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156013

FDA has approved a label update for Kite’s Yescarta (axicabtangene ciloleucel) to include the overall survival primary analysis from the landmark Phase 3 Zuma-7 study that showed a statistically significant improvement for Yescarta in overall survival versus standard of care as second-line treatment with curative intent for patients with relapsed or refractory large B-cell lymphoma within 12 months of completing first-line therapy. A company [news release](https://www.gilead.com/news-and-press/press-room/press-releases/2023/12/us-fda-approves-label-update-for-kites-yescarta-car-tcell-therapy-to-include-overall-survival-data?ref=fdaweb.com) says the study demonstrated a 27.4% reduction in the risk of death with Yescarta versus standard of care, a relative 38% improvement in overall survival.

Yescarta is described as a CD19-directed genetically modified autologous T-cell immunotherapy indicated to treat:

- adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy;
- adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and diffuse large B-cell lymphoma arising from follicular lymphoma; and
- adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.