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 an integrated safety analysis from clinical studies that characterize the potential serious risk of long-term adverse effects of pralsetinib on growth and development, including an assessment of growth plate abnormalities in a sufficient number of adolescent patients 12 years of age and older with RET mutant MTC and RET fusion-positive thyroid cancer. Patients will be monitored for growth and development using age-appropriate screening tools such as Tanner staging. Evaluations will include growth as measured by height, weight, height velocity and height standard deviation scores, age at adrenarche if applicable (males), age at menarche if applicable (females) and Tanner stage. Patient monitoring will be performed until discontinuation of study treatment or a minimum of 5 years from start of treatment, whichever occurs first. Include the datasets with the final report. The results from this study may inform product labeling.

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

2033/4/30 0:00:00

CDER/CBER

CD

子类型标记

F