美国食品和药物管理局批准新组合疗法作为扩散阶段小细胞肺癌的第一线维持治疗,改善生存率和无进展时间.
FDA approves new combo therapy as first-line maintenance treatment for extensive-stage small cell lung cancer, improving survival and progression-free time.
美国食品和药物管理局批准了lurbinectedin加上阿提索利祖马布或阿提索利祖马布与氨酸基酶-tqjs作为一线维持治疗,用于患有扩散阶段小细胞肺癌的成年人,在初始治疗后,他们的疾病没有进展.
The FDA has approved lurbinectedin plus atezolizumab or atezolizumab with hyaluronidase-tqjs as first-line maintenance therapy for adults with extensive-stage small cell lung cancer whose disease hasn’t progressed after initial treatment.
基于第3阶段的IMFORTE试验,合并将中位无累进性存活率提高到5.4个月,将总体存活率中位数提高到13.2个月,而仅使用阿特索利祖马布就有2.1个月零10.6个月。
Based on the phase 3 IMforte trial, the combination improved median progression-free survival to 5.4 months and median overall survival to 13.2 months, compared to 2.1 months and 10.6 months with atezolizumab alone.
批准是这一环境的第一个维持疗法,在护理方面大有进步,尽管它增加了血解毒性的风险,需要仔细挑选病人。
The approval marks the first maintenance therapy for this setting, offering a significant advance in care, though it carries increased risks of hematologic toxicity, requiring careful patient selection.