通用名称

paclitaxel

儿科标签批准日期

2019/12/6 0:00:00

特定指示/秒

Recurrent or refractory pediatric solid tumors

标签更改摘要

- Safety and effectiveness in pediatric patients have not been established. - Pharmacokinetics, safety, and antitumor activity were assessed in an open-label, dose escalation, dose expansion study in 96 pediatric patients aged 1.4 to < 17 years with recurrent or refractory pediatric solid tumors. - The maximum tolerated dose (MTD) normalized for body surface area (BSA) was lower in pediatric patients compared to adults. - No new safety signals were observed in pediatric patients across these studies. - Paclitaxel protein-bound exposures normalized by dose were higher in 96 pediatric patients aged 1.4 to < 17 years as compared to those in adults.

治疗类别

N/A

立法类型

BPCA Only

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