原始来源记录
决策级临床试验登记变更
ADCT：FDA在LOTIS-5 pre-sBLA会议中指出获益-风险担忧
FDA对LOTIS-5 III期试验的获益-风险特征及临床获益验证表达了重大担忧，原因是5级事件失衡且治疗获益仅为边际性。因此，ADC Therapeutics现正重新评估ZYNLONTA获得完全批准并推进至DLBCL更早治疗线的监管路径，而非直接提交sBLA。
关键事实
- 申报时间
- 2026年8月13日 13:14
- 事件
- 临床试验登记变更
- 方向
- 消极
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
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