通用名称

sunitinib malate

儿科标签批准日期

2019/5/7 0:00:00

特定指示/秒

Refractory solid tumors

标签更改摘要

- Safety and effectiveness in pediatric patients have not been established. - Safety and pharmacokinetics were assessed in an open-label study in pediatric patients 2 years to <17 years of age (n=29) with refractory solid tumors. In addition, efficacy, safety and pharmacokinetics was assessed in another open-label study in pediatric patients 2 years to <17 years (n=27) with high-grade glioma or ependymoma. - The maximum tolerated dose normalized for body surface area was lower in pediatric patients compared to adults. - Sunitinib was poorly tolerated in pediatric patients. - The effect on open tibial growth plates in pediatric patients who received Sutent has not been adequately studied. - Information on adverse reactions and clinical trials.

治疗类别

N/A

立法类型

BPCA Only

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