通用名称

entrectinib

儿科标签批准日期

2019/8/15 0:00:00

特定指示/秒

Treatment of adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion with a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy

标签更改摘要

- Safety and effectiveness in pediatric patients aged 12 years and older with solid tumors that have an NTRK gene fusion have been established. - The effectiveness in adolescent patients was established based on extrapolation of data from three open-label, single-arm clinical trials in adult patients with solid tumors harboring an NTRK gene fusion (ALKA, STARTRK-1, and STARTRK-2) and pharmacokinetic data in adolescents enrolled in STARTRK-NG. - Safety in pediatric patients 12 years and older was established based on extrapolation of data in adults and data from 30 pediatric patients enrolled in STARTRK-NG. - Due to the small number of pediatric and adult patients, it is not possible to determine whether the observed differences in the incidence of adverse reactions to Rozlytrek are related to patient age or other factors. In an expanded safety database that included 338 adult patients and 30 pediatric patients who received Rozlytrek across clinical trials, the Grade 3 or 4 adverse reactions and laboratory abnormalities that occurred more frequently in pediatric patients (n = 30) compared with adults (n = 338) were neutropenia (27% vs 2%), bone fractures (23% vs 5%), increased weight (20% vs 7%), thrombocytopenia (10% vs 0.3%), lymphopenia (7% vs 1%), increased gamma-glutamyl transferase (7% vs 0%), and device-related infection (7% vs 0.3%). - Safety and effectiveness in pediatric patients less than 12 years with solid tumors who have an NTRK gene fusion have not been established. - Safety and effectiveness in pediatric patients with ROS1-positive NSCLC have not been established. - Information on dosing, PK parameters, adverse reactions including drug-drug interactions, lab abnormalities, and clinical trial. - New drug.

治疗类别

N/A

立法类型

BPCA Only

产品说明书链接

书号

2.0 1.0

研究年龄

0 YEARS - 21 YEARS 4 YEARS - 20 YEARS

学习类型

Efficacy,Safety Efficacy,Safety,Pharmacokinetic

研究设计

Multicenter,Open-Label,Phase 2,Pooled Safety Multicenter,Open-Label,Dose Finding,Phase 1,Dose Escalation, Expansion Study

登记的患者

30 16

患者分析

30 16

中心的数量

N/A 8

国家数量

N/A 1

西班牙裔拉美裔/拉丁裔总计

N/A 1

非西班牙裔/非拉丁裔总人数

N/A 13

总数#种族不明

N/A 2

亚裔学生总数

N/A 0

黑人总数

N/A 3

白人总数

N/A 13

夏威夷或太平洋岛民总数

N/A 0

美洲印第安人/阿拉斯加本地人总数

N/A 0

其他种族总计

N/A 0

未知种族总数

N/A 0

国家

N/A United States