> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Removes Use Limitation for Yescarta in Rare Lymphoma
- URL: https://www.fdaweb.com/fda-removes-use-limitation-for-yescarta-in-rare-lymphoma/
- Published: 2026-02-06T12:00:00.000Z
- Updated: 2026-09-14T15:32:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160621

FDA has approved a Kite Oncology labeling update for CAR-T therapy Yescarta (axicabtagene ciloleucel), removing a previous limitation on its use in patients with relapsed or refractory primary central nervous system lymphoma (PCNSL), a rare and aggressive form of non-Hodgkin lymphoma. The decision expands access to axicabtagene ciloleucel for a patient population that has historically had few treatment options and poor outcomes, according to the company.

The label update was based on data from a Phase 1 investigator-sponsored study conducted at Dana-Farber Cancer Institute that evaluated the safety of Yescarta in patients with relapsed or refractory PCNSL. In the study, neurologic toxicities were reported in 85% of treated PCNSL patients, with 31% experiencing Grade 3 neurologic events, the company says. Investigators reported no new safety signals, and Kite says the safety profile was considered manageable in this high-risk population. Grade 3 or 4 adverse events included hypotension, encephalopathy, seizures, gait disturbance, headache, hypoxia, muscular weakness, nausea, fever, thrombosis, and tremor.

PCNSL originates in the brain, spinal cord, eyes, or cerebrospinal fluid and accounts for roughly 1,500 new cases annually in the U.S., Kite says. More than half of patients relapse after initial therapy, and median survival following relapse is estimated at about two months, it says, adding that five-year survival rates remain near 30%.

Yescarta is described as a CD19-directed autologous CAR-T cell therapy approved for multiple forms of relapsed or refractory large B-cell lymphoma and follicular lymphoma. The removal of the limitation of use does not change the therapy’s boxed warning or other safety requirements, the company notes.