KTE-C19 (Yescarta®, Axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy first approved by the U.S. Food and Drug Administration on October 18 2017 and by the European Commission in June 2018.
Yescarta® is the first chimeric antigen receptor (CAR) T-cell immunotherapy approved for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (tFL). The approval label was expanded in March 5 2021 to include R/R indolent follicular lymphoma and most recently on April 1 2022, the label was further expanded to include 2L LBCL patients based on the Zuma-7 clinical trial.
Clinical data that supported the first approval application was published in Lancet Oncol.
Over the past 20 years, LLS has invested $40 million in CAR T, helping to pioneer this life-saving technology.
The Leukemia & Lymphoma Society's Therapy Acceleration Program® (TAP) committed $2.5 million in a partnership with Kite Pharma between 2015-2017 to advance the new therapy. The clinical study that led to approval by the FDA was supported in part by LLS TAP. Kite was acquired by Gilead in 2017.