繁体中文
设为首页
加入收藏
当前位置:药品说明书与价格首页 >> 肿瘤 >> 白血病 >> 药品推荐 >> XOSPATA Tablets(Gilteritinib Fumarate)

XOSPATA Tablets(Gilteritinib Fumarate)

2018-12-05 13:29:53  作者:新特药房  来源:互联网  浏览次数:19  文字大小:【】【】【
简介: 英文药名:XOSPATA Tablets(Gilteritinib Fumarate) 中文药名:富马酸吉特替尼片 生产厂家:安斯泰来制药药品介绍Gilteritinib fumarate由安斯泰来研发,于2018年9月21日获日本医药品医疗器械综合机 ...

英文药名:XOSPATA Tablets(Gilteritinib Fumarate)

中文药名:富马酸吉特替尼片

生产厂家:安斯泰来制药
药品介绍
Gilteritinib fumarate由安斯泰来研发,于2018年9月21日获日本医药品医疗器械综合机构(PMDA)批准上市,商品名为Xospata。它是一种FLT3/AXL抑制剂,被批准用于治疗FLT3突变阳性的复发或难治性急性髓细胞白血病。

ゾスパタ錠40mg

药效分类名
抗恶性肿瘤(FT3阻碍剂)
批准日期:2018年11月
商標名
XOSPATA Tablets 40mg
一般名
ギルテリチニブフマル酸塩(Gilteritinib Fumarate)
化学名
6-Ethyl-3-{3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]anilino}-5-[(oxan-4-yl)amino]pyrazine-2-carboxamide hemifumarate
構造式

分子式
(C29H44N8O3)2・C4H4O4
分子量
1221.50
性状
Gilteritinib Fumarate是淡黄色~黄色的粉末或结晶。水不易融化,乙醇(99.5)很难融化。
批准条件
1 .在制定医药品风险管理计划的基础上,适当地实施。
2早期收集剂的安全性及有效性的数据,以合理使用本剂的适当措施。
药效药理
1 .作用机制
金属配料:吉折里奇尼布表示对ft3等的g30胶激烈的调试作用,调试效果ft3的信号牵,抑制配料ft3的金属丝,遏制配料ft3的旋律。
2 .抗肿疙瘩效果
vito试验
吉砧里奇尼布对配料的人急性骨髓性白血病的mv 4-11细胞股显示了增殖多人。(2) in看法考试
13交换细胞移植的裸体老鼠标尺中,显示了抑制肿疙瘩增殖。
适应症
复发或难治性flt3基因变异阳性急性骨髓性白血病
用法与用量
成年人;每天服一次,每次服用120毫克天。另外,虽然根据患者的情况适当增减,但一天不超过200毫克。
临床成绩
国际共同第III相临床成绩
以第一次复发或难治性的FT3基因变异阳性注1)的急性骨髓性白血病患者(FT3-I-I-TKD变异注2)、FTS3-TKD变异注3)或FTS3-I-I-TKD变异以及FTT3-TKD变异的情况下,1日连续连续多次投入本剂120mg(包括无作为例数142例,日本人18例))。
主要评价项目的一个,第一次中间分析的本剂群的CR注4)或是基准注5)率为36.2%(40/142例)(95%信任区间:20.9%~36.3%)。另外,CR率为19.0%(27/142例,95%信任区间:12.9%~26.4%),基准率为9.2%(13/142例,95%,信任区间:5.0%~15.1%)(2017年8月4日)。
注1)在FT3基因变异检查中使用了Ruret CDxFT3变异检查。
Rut成本拉特CDxFT3变异检查是作为联合诊断药的制造销售许可。
注2)FT3-ID变异:内部纵列重复变异
注3)FTT3-TKD变异:D835或I836的氨酸激酶域变异
注4)CR是骨髓的正常造血细胞再生,在形态学上不承认白血病细胞,骨髓中的芽球数不到5%,好中球绝对数是1.0×109/L以上,且血小板数是100×109/L以上,没有进行红血球和血小板输血,是髓外性白血病没有被认可的状态。
注5)在骨髓中的芽球数不到5%,好中球绝对数为0.5×109/L以上,而且血小板数是50×109/L以上,是髓外性白血病不被认可的状态。
包装
42錠(21錠×2)


制造销售
安斯泰来制药
注:以上中文处方资料不够完整,使用者以原处方资料为准。
完整说明书附件:http://www.info.pmda.go.jp/go/pack/4291053F1021_1_02/
Gilteritinib fumarate
Gilteritinib fumarate by Ann's research and development, on September 21, 2018, Japan's pharmaceuticals (PMDA) approved medical equipment integrated mechanism, commodity called Xospata®. It is a FLT3/AXL inhibitor approved for the treatment of recurrent or refractory acute myeloid leukemia with positive FLT3 mutations.
Acute myeloid leukemia (AML) is a group of highly heterogeneous clonal diseases with unique characteristics of cellular morphology, immunophenotype, cytogenetics and molecular genetics.
Some reproducible gene mutations have been confirmed to be important factors in AML diagnostic typing, risk stratification and prognosis evaluation, and some specific targeted drugs targeting the mutated genes have gradually entered clinical studies.
Acute myeloid leukemia (AML) accounts for more than 50% of acute leukemia and is more common in adults aged 40. Acute myeloid leukemia can lead to anemia, bleeding, fever and other clinical symptoms, not only is not conducive to the health of patients, but also to the life of patients with a threat.
Xospata ® approval is based on a clinical phase iii trials in the multinational (NCT02421939) interim results in the study of CR/CRh2 analysis. ADIMRAL aim was to compare Xospata ® and save chemotherapy with FLT3 mutations and the first-line therapy for recurrent or refractory adult AML. 2:1 according to the proportion of patients randomized to receie Xospata(120 mg) or save chemotherapy, Xospata ® has been proven to inhibit FLT3 tandem copies and PLT in the activity of tyrosine kinase domain structure mutation. These two mutations are present in about one-third of AML patients.
Compared with other cancers, acute myeloid leukemia is still a relatively rare disease: the incidence rate in China is 162/100,000, lower than that in the United States (436/613/100,000) and Japan (325/585/100,000). Although they may be primary or secondary, they are the result of radiation exposure, carcinogenic chemical exposure, or have been the result of other blood diseases, such as myelodysplastic syndrome or myeloproliferative disorder. Men are slightly higher than women in the patient population. Xospata ® listed to cure acute myelogenous leukemia provides new options.

责任编辑:p53


相关文章
XOSPATA tablets(gilteritinib 舒必泰片)
 

最新文章

更多

· XOSPATA Tablets(Gilte...
· XOSPATA tablets(gilter...
· Daurismo(glasdegib Tab...
· BLINCYTO 35μg vial(B...
· Copiktra(duvelisib Cap...
· KYMRIAH(tisagenlecleuc...
· Lumoxiti injection pow...
· Tibsovo(Ivosidenib Tab...
· Rydapt 25mg capsules(...
· Alkeran for injection(...

推荐文章

更多

· XOSPATA Tablets(Gilte...
· XOSPATA tablets(gilter...
· Daurismo(glasdegib Tab...
· BLINCYTO 35μg vial(B...
· Copiktra(duvelisib Cap...
· KYMRIAH(tisagenlecleuc...
· Lumoxiti injection pow...
· Tibsovo(Ivosidenib Tab...
· Rydapt 25mg capsules(...
· Alkeran for injection(...

热点文章

更多

· Daurismo(glasdegib Tab...
· XOSPATA tablets(gilter...
· BLINCYTO 35μg vial(B...
· XOSPATA Tablets(Gilte...