一次情報の記録
決定級FDA 承認
Nuvation Bio:IBTROZI(taletrectinib)、進行ROS1陽性NSCLCに対し2025年6月に承認
The 8-K confirms U.S. FDA approval of IBTROZI on June 11, 2025 for advanced ROS1+ NSCLC (line-agnostic). The company reports 204 new patient starts in Q3 2025 and 80% payor coverage, establishing commercial traction. Updated August 2025 data show median DOR of 50 months in TKI-naïve patients, supporting a planned supplemental NDA filing by year-end 2025.
主要事実
- 提出
- 2025年11月26日 13:34
- イベント
- FDA 承認
- 方向
- ポジティブ
- アセット
- taletrectinib
- 出典
- SEC 8-K
- 信頼度
- 出典あり
- TKI未治療cORR
- 89%
- 保険適用
- 80%
- TKI未治療のDOR中央値
- 50ヶ月
- 2025年第3四半期開始患者
- 204
出典の抜粋
EX-99.1 2 d82457dex991.htm EX-99.1 EX-99.1 DRIVEN BY SCIENCE FOCUSED ON LIFE November 2025 Exhibit 99.1 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 not