申请企业

BLUEPRINT MEDICINES CORP

药品名称

GAVRETO (pralsetinib) 400 mg (once daily)

状态

未解决

承诺描述

Submit the final report of integrated studies and datasets, to verify and further characterize the clinical benefit of pralsetinib for the treatment of patients with RET fusion-positive thyroid cancer who have received radioactive iodine (if appropriate for their tumor histology) to provide a more precise estimation of the BICR-assessed overall response rate and duration of response in at least 50 patients in a variety of histologies after all responding patients have been followed for 12 months following onset of response or until disease progression, whichever comes first.

承诺状态描述

报告接收日期

批准日期

2020/12/1 0:00:00

截止日期

2025/6/30 0:00:00

CDER/CBER

CD

子类型标记

H