On 18th October 2017, the U.S. Food and Drug Administration (FDA) approved Kite Pharma’s Yescarta (axicabtagene ciloleucil) for the treatment of relapsed or refractory adult diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL).
With this approval, Yescarta, previously called KTE-C19, becomes the second gene therapy approved by the FDA, and the first in the treatment of specific types of non-Hodgkin lymphoma. This approval is based on data from the phase II ZUMA-1 trial (NCT02348216). Primary results from this study were initially presented by Frederick L. Locke at AACR 2017 (view here), then by Sattva S. Neelapu at ICML 2017 (read here), and more recently by Yi Lin at the 22nd Congress of the EHA (click here to read more). Immune signature data of cytokine release syndrome and neurologic events from the trial were also presented by Locke during AACR (view here).
The full indication is as follows:
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Limitation of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma
In August 2017, Kite Pharma submitted a marketing authorization application to the European Medicines Agency (EMA) for axicabtagene ciloleucil (KTE-C19) in the treatment of patients with R/R DLBCL, TFL, and PMBCL who are not eligible for Autologous Stem Cell Transplant (ASCT).