美国食品和药物管理局批准摘要:Teclistamab-A双特异性CD3T细胞激活剂用于复发性或耐火性多发性髓瘤患者
Andrea C Baines1, Bindu Kanapuru1, Jay Zhao1
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
概括
Teclistamab-cqyv为复发性或耐火性多发性髓瘤提供了一种新的治疗方法. 这种双特异性抗体在MajesTEC-1试验中显示了61.8%的响应率,但具有诸如细胞因子释放综合征等风险.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
背景情况:
- 多发性骨髓瘤是一种血细胞的癌症.
- 复发性或耐火性多发性骨髓瘤的治疗选择有限.
- 针对B细胞成熟抗原 (BCMA) 的疗法是一种新的方法.
研究的目的:
- 为了总结支持FDA加速批准teclistamab-cqyv.v.的数据,
- 审查在多发性骨髓瘤中使用teclistamab的疗效和安全性.
- 突出特克利斯塔马布作为第一个针对多发性骨髓瘤的双特异性CD3T细胞参与者.
主要方法:
- 在MajesTEC-1试验 (I/II期,单臂,开放标签,多中心) 中评估了teclistamab.
- 患者接受逐步增加剂量,然后每周进行一次皮下注射.
- 治疗持续到疾病进展或不可接受的毒性.
主要成果:
- 观察到的整体反应率 (ORR) 为61.8%.
- 完全响应或更好的 (≥CR) 率为28.2%.
- 副作用包括细胞因子释放综合征 (72%) 和神经毒性 (57%).
结论:
- Teclistamab-cqyv获得了FDA对复发性/耐药性多发性骨髓瘤的加速批准.
- 这种药物是一种针对BCMA的双特异性抗体和CD3T细胞参与者.
- 由于毒性风险,特克利斯塔马布具有盒装警告和限制分发.
更多相关视频
09:34Dynamic Imaging of Chimeric Antigen Receptor T Cells with [18F]Tetrafluoroborate Positron Emission Tomography/Computed Tomography
Published on: February 17, 2022
3.3K
10:19Tracking Bispecific Antibody-Induced T Cell Trafficking Using Luciferase-Transduced Human T Cells
Published on: May 12, 2023
1.2K
相关概念视频
Targeted Cancer Therapies
The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against specific...
There are several types of targeted therapies against specific...
Tumor Immunotherapy
Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
