原始出處紀錄
決策級臨床試驗登錄異動
ADCT：FDA 在 LOTIS-5 預 sBLA 會議中指出效益風險疑慮
FDA 對 LOTIS-5 第三期試驗的效益風險概況及臨床效益驗證表達重大疑慮，原因在於 5 級不良事件的不平衡以及治療效益僅有邊際改善。因此，ADC Therapeutics 現正重新評估 ZYNLONTA 取得完全核准並推進至 DLBCL 較早期治療線的法規路徑，而非直接提交 sBLA。
關鍵事實
- 申報時間
- 2026年8月13日 下午01:14
- 事件
- 臨床試驗登錄異動
- 方向
- 負面
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
EX-99.1 2 dp251718_ex9901.htm EXHIBIT 99.1 Exhibit 99.1 ADC Therapeutics Reports Second Quarter 2026 Financial Results and Provides Operational Updates Second quarter 2026 net product revenue of $18.6 million; cash and cash equivalents of $219.1 million as of June 30, 2026 LOTIS-7, LOTIS-5 and MZL IIT data submitted for presentation at ASH Company evaluating regulatory path for ZYNLONTA ® to obtain full approval and advance into earlier lines of DLBCL following LOTIS-5 pre-sBLA meeting Company to host conference call today at 8:30 a.m. EDT LAUSANNE, Switzerland, August 13, 2026 – ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the second quarter ended June 30, 2026, and provided recent operational updates. ZYNLONTA ® commercial performance as a monotherapy in