February 6, 2026--SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (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 central nervous system lymphoma (PCNSL). The updated label reinforces the robust safety data of Yescarta in eligible patients with R/R PCNSL; Yescarta is the only CAR T-cell therapy approved for R/R large B-cell lymphoma to have this Limitations of Use removed.
Primary central nervous system lymphoma is a rare and fast‑growing lymphoma that originates in the brain, spinal cord, eye, or cerebrospinal fluid. Prognosis for PCNSL remains poor, with a five‑year survival rate of approximately 30%. More than half of patients see their disease come back after the first treatment, with subsequent survival of approximately two months, highlighting the urgent need for new and better treatment options.
The FDA decision is based on positive results from a Phase 1 investigator-sponsored study conducted by Dana-Farber Cancer Institute, which included patients with R/R PCNSL.
“We are pleased that our study, which highlighted the safety of axi-cel in central nervous system lymphoma, supported the FDA’s decision,” said Lakshmi Nayak, MD, Director of the Center for CNS Lymphoma, Dana-Farber Cancer Institute and Associate Professor of Neurology, Harvard Medical School. “This update to the axi-cel prescribing information provides clinicians with important evidence for patients who have historically had very limited treatment options.”
In the Phase 1 study, neurologic toxicities occurred in 85% (11/13) of patients with R/R PCNSL. Thirty-one percent (4/13) of patients had Grade 3 neurologic toxicities. The Grade 3 or 4 adverse events were hypotension (23%; 3/13), encephalopathy (15%; 2/13), seizure (15%; 2/13), gait disturbance (8%; 1/13), headache (8%; 1/13), hypoxia (8%; 1/13), muscular weakness (8%; 1/13), nausea (8%; 1/13), pyrexia (8%; 1/13), thrombosis (8%; 1/13), and tremor (8%; 1/13).
“We are encouraged by the positive results of the safety study in patients with central nervous system lymphoma, who were previously excluded from the trials supporting Yescarta’s approval,” said Gallia Levy, MD, PhD, Senior Vice President and Global Head of Development, Kite. “We appreciate the FDA’s timely review and decision, which expands access to Yescarta for patients with primary central nervous system lymphoma—one of the most aggressive and underserved forms of the disease—and we are deeply grateful to the patients and clinicians who made this progress possible.”
About Central Nervous System Lymphoma
Central nervous system lymphoma (CNSL) is an aggressive and rare form of non-Hodgkin lymphoma that has either originated in (primary) or spread (secondary) to the brain, eye, spinal cord, or cerebrospinal fluid. There is an estimated annual incidence of 1,500 cases of PCNSL in the United States; it comprises 3% of all primary brain tumors and 1% of all cases of non-Hodgkin lymphoma. Its prognosis has historically been poor, with a five-year survival rate of only 30%. CNSL is most likely to be seen in the elderly and people with a compromised immune system. R/R CNSL is considered an area of unmet clinical need with no standard-of-care treatment options.
About the Study
The Phase 1 safety study enrolled 18 patients (13 PCNSL, 5 SCNSL), of whom the first six patients were observed for treatment-limiting toxicities (TLTs). The primary endpoint was safety, measured by rate of TLTs and ≥ Grade 3 adverse events (AEs). Secondary endpoints included objective response rate, complete response rate, duration of response, progression-free survival and overall survival (OS).
About Yescarta
Please see full Prescribing Information, including BOXED WARNING below and Medication Guide.
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:
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Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
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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.
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Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
About Gilead and Kite Oncology
Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer.