吉利德赢得Yescarta的美国标签更新

2026-02-06 23:02

Gilead’s (GILD) Kite unit announced on Friday that the U.S. Food and Drug Administration approved a label update for its CAR-T therapy Yescarta, removing a limitation that prevented its use in a subset of patients with a rare form of lymphoma.
The revised prescribing information removes Yescarta’s previously limited use in patients with relapsed or refractory ((R/R)) primary central nervous system lymphoma, a rare type of lymphoma that mainly affects the brain and spinal cord.
According to Kite, Yescarta is the first CAR-T therapy approved for R/R large B-cell lymphoma to have this limitation removed.
The FDA decision is supported by favorable safety data from a Phase 1 investigator-sponsored study that tested the autologous T cell immunotherapy in lymphoma patients, including those with R/R PCNSL.

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