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 including datasets from a multi-center, randomized, open-label trial comparing pralsetinib to investigator’s choice of either cabozantinib or vandetanib in multi-kinase inhibitor naïve patients with advanced or metastatic RET-mutant medullary thyroid cancer to confirm the clinical benefit of pralsetinib with progression-free survival as a primary end point, as assessed by blinded independent central review.

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

2028/1/31 0:00:00

CDER/CBER

CD

子类型标记

H