通用名称

daunorubicin/cytarabine

儿科标签批准日期

2021/3/30 0:00:00

特定指示/秒

Newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients ages 1 year and older

标签更改摘要

- Safety and effectiveness have been established in pediatric patients 1 year and older with newly diagnosed t-AML or AML-MRC. - The use for this indication is supported by evidence of effectiveness from an adequate and well-controlled study in adults with data on safety from two single-arm trials, which included patients in the following age groups: 7 patients 1 year to less than 2 years old, 33 patients 2 years to less than 12 years old, 13 patients 12 years old to less than 17 years old. - No new safety signals were observed in pediatric patients in these two single-arm trials. - No differences in safety were observed by age. - Safety and effectiveness in pediatric patients less than 1 year of age with newly-diagnosed t-AML or AML-MRC have not been established. - Information on dosing, adverse reactions, PK parameters, and clinical trials.

治疗类别

N/A

立法类型

BPCA Only

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