FDA

FDA lifts key limitation on Yescarta use in primary CNS lymphoma

February 10, 2026

On February 6, 2026, FDA approved an update to the Yescarta (axicabtagene ciloleucel) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary CNS lymphoma (PCNSL).

The decision was based on positive results from a phase 1 investigator-sponsored study (NCT04608487), which included 18 patients with R/R CNSL (13 had PCNSL, 5 had secondary CNS lymphoma). Primary endpoint was safety, measured by rate of treatment-limiting toxicities and ≥grade 3 adverse events. Secondary endpoints included objective response rate, complete response rate, duration of response, progression-free survival and overall survival (OS).

Neurologic toxicities occurred in 85% (11/13) of patients with R/R PCNSL. Thirty-one percent of patients had grade 3 neurologic toxicities. Grade 3 or 4 adverse events included hypotension (23%), encephalopathy (15%), seizure (15%), gait disturbance (8%), headache (8%), hypoxia (8%), muscular weakness (8%), nausea (8%), pyrexia (8%), thrombosis (8%), and tremor (8%).

Sources:

FDA approves label update for Kite’s Yescarta® for relapsed/refractory primary central nervous system lymphoma. [News release]. Kite Pharma. https://www.kitepharma.com/news/press-releases/2026/2/fda-approves-label-update-for-kites-yescarta-for-relapsedrefractory-primary-central-nervous-system-lymphoma

Yescarta (axicabtagene ciloleucel) [package insert]. Kite Pharma. https://www.gilead.com/-/media/files/pdfs/medicines/oncology/yescarta/yescarta-pi.pdf Revised February 2026. Accessed February 9, 2026.