Onco-Summaries: Daily Oncology Updates at a Glance

06/02/2026

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• The FDA approved a label update for Yescarta for Relapsed/Refractory Primary Central Nervous System Lymphoma

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The FDA approved a label update for Yescarta for Relapsed/Refractory Primary Central Nervous System Lymphoma (Ref)

The US FDA approved an update to Gilead's Yescarta® (axicabtagene ciloleucel; anti-CD19 CAR T-cell therapy) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL).

• 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.

• Lakshmi Nayak, MD, Director of the Center for CNS Lymphoma, Dana-Farber Cancer Institute and Associate Professor of Neurology, Harvard Medical School: “We are pleased that our study, which highlighted the safety of axi-cel in central nervous system lymphoma, supported the FDA’s decision. This update to the axi-cel prescribing information provides clinicians with important evidence for patients who have historically had very limited treatment options.”