我们重视您的隐私
我们使用 Cookie 分析网站流量并改善您的体验。请参阅我们的隐私政策。
隶属于 吉利德科学
相关临床试验
67
40 进行中
药物批准
2
批准总数
监管机构
监管机构数
成立时间
2009
进行中(未招募)
37
55.2%
Approved For Marketing
3.0%
Available
已完成
11
16.4%
Enrolling By Invitation
尚未招募
1
1.5%
招募中
4
6.0%
终止
8
11.9%
FDA
Food and Drug Administration
SFDA
Saudi Food and Drug Authority
- A recent study suggests that the FDA's Risk Evaluation and Mitigation Strategy (REMS) for CAR T-cell therapy may be overly restrictive, impacting patient accessibility. - The study found that the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) is low after the first two weeks post-CAR T infusion. - Researchers propose a more flexible approach to monitoring, with a mandatory 2-week period near the treatment center, followed by individualized assessments. - Revisiting REMS mandates could reduce the physical and financial burden on patients, potentially improving access to CAR T-cell therapy, especially for underserved populations.