申请企业

Novartis Pharmaceuticals Corporation

药品名称

KYMRIAH, Tisagenlecleucel

状态

未间断

承诺描述

A post-marketing, prospective, multi-center, observational study to assess the long-term safety of tisagenlecleucel and the risk of all secondary malignancies occurring after treatment with tisagenlecleucel. The study will include at least 1000 pediatric and young adult patients with relapsed / refractory B cell acute lymphoblastic leukemia; the enrolled patients will be followed for 15 years after the product administration.

承诺状态描述

报告接收日期

2020/10/26 0:00:00

批准日期

2017/8/30 0:00:00

截止日期

2038/12/31 0:00:00

CDER/CBER

CB

子类型标记

F