通用名称

dasatinib

儿科标签批准日期

2018/12/21 0:00:00

特定指示/秒

Pediatric patients one year and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy

标签更改摘要

- Safety and effectiveness of Sprycel in combination with chemotherapy have been demonstrated in pediatric patients one year and over with newly diagnosed Ph+ ALL. - Use in pediatric patients is supported by evidence from one pediatric study. There are no data in children under 1 year. - The safety profile in pediatric patients was comparable to that reported in studies in adults. - Monitor bone growth and development in pediatric patients. - Five patients with Ph+ ALL 2 to 10 years of age received at least one dose of SPRYCEL tablet dispersed in juice. The exposure for dispersed tablets was 36% lower as compared to intact tablets in pediatric patients. Due to the limited available clinical data, it is unclear whether dispersing Sprycel tablets significantly alters the safety and/or efficacy of Sprycel. - New indication

治疗类别

N/A

立法类型

BPCA Only

产品说明书链接

书号

4.0 3.0 2.0 1.0

研究年龄

1 YEARS - 17 YEARS 1 YEARS - 17 YEARS 1 YEARS - 29 YEARS 1 YEARS - 17 YEARS

学习类型

Historical Control Historical Control Efficacy,Safety Efficacy,Safety

研究设计

Multicenter,Open-Label n,a Multicenter,Open-Label,Non-Randomized,Single Arm Multicenter,Open-Label,Non-Randomized,Single Arm,Historically-Controlled

登记的患者

155 61 63 109

患者分析

N/A N/A N/A 106

中心的数量

11 127 47 70

国家数量

N/A N/A 4 5

西班牙裔拉美裔/拉丁裔总计

N/A N/A 10 24

非西班牙裔/非拉丁裔总人数

N/A N/A 45 55

总数#种族不明

N/A N/A 0 0

亚裔学生总数

N/A N/A 3 5

黑人总数

N/A N/A 9 13

白人总数

N/A N/A 44 85

夏威夷或太平洋岛民总数

N/A N/A 1 1

美洲印第安人/阿拉斯加本地人总数

N/A N/A 2 1

其他种族总计

N/A N/A 3 1

未知种族总数

N/A N/A N/A N/A

国家

N/A N/A N/A N/A