业界动态监管公开信息 · FDA
FDA授予lisocabtagene maraleucel加速批准用于滤泡性淋巴瘤
FDA Drugs · 2026-11-10 05:52
摘要
2024年5月15日，美国食品药品监督管理局（FDA）授予lisocabtagene maraleucel（Breyanzi，Juno Therapeutics， Inc.）加速批准，用于既往接受过两线或以上系统性治疗的复发或难治性滤泡性淋巴瘤（FL）成人患者。
English
FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma
On May 15, 2024, the Food and Drug Administration granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.