![Dynamic Imaging of Chimeric Antigen Receptor T Cells with [18F]Tetrafluoroborate Positron Emission Tomography/Computed Tomography](/_next/image?url=https%3A%2F%2Fcloudfront.jove.com%2FCDNSource%2Fteasers%2F62334.jpg&w=3840&q=50)
美国食品和药物管理局批准摘要:利索卡巴泰基因马拉莱塞尔用于复发性或耐火性囊性淋巴瘤
Kristen Britton1, Upendra Mahat1, Nicholas C Richardson1
1United States Food and Drug Administration, Silver Spring, MD, United States.
概括
利索卡巴丁马拉莱塞尔 (Lisocabtagene maraleucel) 获得了FDA对复发性或耐火性卵泡淋巴瘤 (FL) 的加速批准. TRANSCEND-FL试验显示了高响应率,95.7%的整体响应和73.4%的R/R FL患者的完整响应.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 毛囊性淋巴瘤 (FL) 是一种惰性非霍奇金淋巴瘤.
- 复发性或耐火性 (R/R) FL 存在治疗方面的挑战.
- 利索卡巴丁基马拉莱塞尔是一种CAR T细胞疗法.
研究的目的:
- 为了总结利索卡巴泰基因maraleucel对R/R FL的监管审查.
- 提出有效性和安全性数据支持其加速批准.
主要方法:
- 第二阶段,单臂,开放标签,多中心 TRANSCEND-FL试验.
- 评估了R/R惰性非霍奇金淋巴瘤的成年人中的 lisocabtagene maraleucel.
- 主要疗效群体:94名患有R/RFL和≥2次先前治疗的患者.
主要成果:
- 总体应答率 (ORR):95.7% (95% CI:89.5,98.8). 总体应答率 (ORR):95.7% (95% CI:89.5,98.8) 总体应答率 (ORR) 总体应答率 (ORR) 总体应答率 (ORR) 总体应答率 (ORR) 总体应答率 (ORR) 总体应答率 (ORR) 总体应答率 (ORR) 总体应答率 (ORR) 总体应答率 (ORR) 总体应答率 (ORR) 总体应答率 (ORR)
- 完整反应 (CR) 率: 73.4% (95% CI: 63.3, 82.0). 没有任何反应.
- 响应的平均持续时间未达到;1年缓解率:81%.
结论:
- 利索卡巴丁马拉莱塞尔在R/R FL中表现出显著的疗效.
- 获得了加速批准,需要进行营销后研究.
- 副作用包括细胞因子释放综合征和神经毒性.
更多相关视频
06:08Assessment of Chimeric Antigen Receptor T Cell-Associated Toxicities Using an Acute Lymphoblastic Leukemia Patient-Derived Xenograft Mouse Model
Published on: February 10, 2023
1.4K
06:51Manufacturing Chimeric Antigen Receptor CAR T Cells for Adoptive Immunotherapy
Published on: December 17, 2019
15.3K
相关概念视频
02:57Targeted Cancer Therapies
7.8K
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...
There are several types of targeted therapies against...
7.8K
02:56Treatment Resistant Cancers
3.4K
Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
3.4K