原始来源记录
决策级FDA 说明书更新
Nuvation Bio：IBTROZI（taletrectinib）中位DOR更新至50个月
2025年8月数据截止显示，TKI初治患者的中位缓解持续时间增至50个月，支持计划于2025年底提交补充NDA。这强化了已获批的IBTROZI在晚期ROS1+ NSCLC中的临床特征。
关键事实
- 申报时间
- 2025年11月17日 22:31
- 事件
- FDA 说明书更新
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- 确认客观缓解率
- 89%（汇总）
- 中位无进展生存期
- 46个月
- 中位缓解持续时间
- 50个月
来源摘录
EX-99.1 2 d845081dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 DRIVEN BY SCIENCE FOCUSED ON LIFE November 2025 Forward-looking statements Certain statements included in this presentation (this “Presentation”) that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may，” “will，” “estimate，” “continue，” “anticipate，” “intend，” “expect，” “should，” “would，” “plan，” “predict，” “potential，” “seem，” “seek，” “future，” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are no