申请企业

Kite Pharma Inc.

药品名称

TECARTUS, brexucabtagene autoleucel

状态

未解决

承诺描述

A post-marketing, prospective, multi-center, observational study to assess the long-term safety of brexucabtagene autoleucel and the risk of secondary malignancies occurring after treatment with brexucabtagene autoleucel. The study will include at least 500 adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy; the enrolled patients will be followed for 15 years after the product administration. Final Protocol Submission: August 31, 2020 Study Completion Date: August 31, 2040 Final Report Submission: August 31, 2041

承诺状态描述

报告接收日期

批准日期

2020/7/24 0:00:00

截止日期

2041/8/31 0:00:00

CDER/CBER

CB

子类型标记

F