申请企业

Kite Pharma Inc.

药品名称

TECARTUS, brexucabtagene autoleucel

状态

未解决

承诺描述

Complete additional follow-up of all 68 subjects treated with brexucabtagene autoleucel in ZUMA-2 Cohort 1 to a minimum of 18 months from the time of first response. Data will continue to be collected according to the ZUMA-2 protocol’s established schedule of assessments. Final Protocol Submission: Submitted November 13, 2018 Study/Trial Completion: December 31, 2020 Final Report Submission: July 31, 2021

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

2021/7/31 0:00:00

CDER/CBER

CB

子类型标记

H