Kadcyla-曲妥珠单抗-ado-trastuzumab-emtansine | 说明书 价格 - 美国 香港 澳门 台湾 新加坡 中国大陆 哪里购买 上市信息药品服务许可证(京)-经营-违法不良信息举报: 电话、邮箱youkujubao@service.alibaba.com请使用者仔细阅读优酷、、、、和Copyright(C)2018 优酷 youku.com 版权所有帕妥珠单抗PERJETA和 曲妥珠单抗KADCYLA香港价钱多少? 华特药房_有谁买过?_百度知道
帕妥珠单抗PERJETA和 曲妥珠单抗KADCYLA香港价钱多少? 华特药房_有谁买过?
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我们会通过消息、邮箱等方式尽快将举报结果通知您。近日，美国FDA正式授予日本Daiichi Sankyo公司抗癌新药DS-8201突破性疗法认定，用于治疗既往接受帕妥珠单抗、曲妥单抗以及经ado-trastuzumab emtansine（T-DM1）治疗后出现病情恶化的HER2阳性，局部晚期或转移性乳腺癌患者。一般获得突破性疗法认定的药物，FDA会给与优待，在后续审批和上市过程中，开放绿色通道。乳腺癌是全球女性发病率最高的癌症，约有五分之一的乳腺癌患者会表达HER2，这是一种在癌细胞表面发现的酪氨酸激酶受体生长促进蛋白，与侵袭性疾病相关。截至目前为止，尚未有任何一款药物获批用于经HER2靶点治疗药物（曲妥单抗、帕妥珠单抗以及T-DM1）治疗无效的HER2阳性转移性乳腺癌，这一领域还有巨大的医疗需求未被满足，此次突破疗法的授予，将极大推动DS-8201上市的审批进程。DS-8201是又一个抗体耦联药物（ADC），ADC药物是采用特定的连接子将抗体和小分子细胞毒药物连接起来，其主要组成成分包括抗体、连接子和小分子细胞毒药物（smallmolecular cytotoxic drug，SM）。抗体分子主要发挥靶向投递作用，小分子药物发挥效应，也就是说，依靠抗体把化疗药精准的带到癌细胞身边，然后毒死他。这类药物疗效更加直接有效，副作用更小，是近几年抗癌药研发领域的新星。HER2阳性的乳腺癌目前为止已经有不少靶向药：赫赛汀、帕妥珠单抗、T-DM1、拉帕提尼、来那替尼等，此类患者属于不幸中的万幸。但依然有一部分病人，对上述药物全部耐药，并且人数不在少数。此外，HER2阳性的癌症还见于肺癌、肠癌、胆管癌、胃癌等多种肿瘤，因此新药的开发迫在眉睫。在纳入22例患者（16例乳腺癌，5例胃癌，1例胃食管结合部腺癌）的剂量递增试验中显示，每3周给予1次DS-8201a（0.8-8.0 mg/kg），最大耐受剂量仍未达到，也没有体现出剂量限制性毒性。最常见的不良反应主要为轻到中度的胃肠道和血液反应。3例患者报告了7件3级不良反应事件，包括低钾血，贫血，中性粒细胞计数降低，淋巴细胞计数降低，ALP增加和胆管炎。20例可评价患者的初步疗效分析数据显示，DS-8201a实现了35%的客观应答率（7例部分缓解）。疾病控制率达到90%，包括12例既往接受过ado-trastuzumab emtansine (T-DM1)治疗和5例HER2低表达者（IHC2+/FISH- or IHC1+）的患者。在15例HER2+患者（IHC3+ or IHC2+/FISH+）中，疾病控制率更达到了100%。目前有17名患者仍在接受DS-8201a治疗，有5例患者接受治疗的时间超过了24周，中位无进展生存期尚未到达。目前，DS-8201用于难治性HER2阳性的乳腺癌，二期临床试验已经启动，让我们翘首期盼。乳腺癌的最新靶向药列表一览疾病靶点通用名商品名大陆是否上市乳腺癌CDK4 CDK6Palbociclib(帕博西尼)Ibrance×HER2(ERBB2/nue)Ado-trastuzumab emtansine (TDM-1)Kadcyla×Pertuzumab（帕妥珠单抗）Perjeta×Trastuzumab（曲妥珠单抗）Herceptin（赫赛汀）√Lapatinib（拉帕替尼）Tykerb（泰立沙）√EGFR(HER1/ERBB1)mTROEverolimus（依维莫司）飞尼妥√HR(+) HER2(-)Kisquali×Goserelin（戈舍瑞林）Zoladex（诺雷得）√Afatinib（阿法替尼）Giortif×Bendamustine （苯达莫司汀）Treanda×Melphalan（马尔法兰）Alkeran×Eribulin mesylate(甲磺酸艾瑞布林)Halaven×治癌国宝级中药――樟芝液主要原料：牛樟芝萃取物原料产地：台湾功效成分：三萜类、多糖体（主要为β-葡聚糖）、腺苷、小苯环类等数十种药理成分，具有抗肿瘤、抗病毒、抗炎症、改善肝脏功能、免疫调节等多种功效。规格：50ml/瓶建议服用量：每次1瓶，每天1-5次储存方法：置于通风、阴凉、干燥、清洁、无异味处，避免阳光直射或靠近热源
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违法和不良信息举报：zl@nlaw.orgKadcyla (trastuzumab-emtansine
conjugate) is a novel antibody-drug conjugate that has been approved by the US
FDA for the treatment of HER2-positive static breast cancer. Transfer is often
seen as a sign of late disease, meaning that the tumor has spread to other parts
of the body. HER2 is a protein that promotes normal cell growth and is highly expressed
in a series of cancer cell lines (called HER2-positive), which includes several
breast cancer cells. HER2 protein promotes the growth and survival of HER2-positive
breast cancer cells.
is a short form of human epidermal growth factor receptor 2. Kadcyla can be used
in patients treated with anti-HER2 regimen, anti-HER2 treatment program is widely
used in breast cancer chemotherapy, related drugs, including trastuzumab, and taxanes
and so on.
Kadcyla is a conjugate of trastuzumab in combination with another drug, DM1, which
interferes with the growth of tumor cells,& said Dr. Richard Pazdur, director
of hematological oncology at the Center for Drug Evaluation and Research at the
FDA. Kadcyla can target drugs to the tumor site, thereby reducing the tumor, delaying
disease progression and prolonging survival. It is the fourth approved HER2 protein
targeting drug.
was called T-DM1 during the study, which first obtained FDA's pre-qualification
and reduced the entire approval process to six months. This process is applicable
to drugs that do not have effective therapies and exhibit good safety and efficacy,
or a significant improvement in the market's circulation of drugs.
experts reviewed the safety and efficacy of Kadcyla in the EMILIA study, which
included 991 patients and were randomized into two groups: the Kadcyla and lapatinib
combined with capecitabine (capecitabine Is another chemotherapy drug). The patient
is treated continuously until the disease progresses or the side effects of the
drug are unbearable. The primary end point of the study was: progression-free survival
(the time of cancer re-development), overall survival (patient survival time).
The progression-free survival of the patients in the Kadcyla group was 9.6 months,
compared with 6.4 months for patients with lapatinib combined with capecitabine.
The median overall survival of the patients in the Kadcyla group was 30.9 months,
with a median overall survival of 25.1 months for patients with lapatinib combined
with capecitabine.
for Kadcyla, the FDA gives a rare &Boxed Warning&. FDA must warn doctors
and patients that Kadcyla may cause heart toxicity, liver toxicity, and death.
It may also cause serious or even life-threatening embryonic developmental defects.
Pregnant women with caution. Kadcyla clinical studies reported side effects including
joint pain, muscle pain, thrombocytopenia (low blood platelet levels), elevated
levels of liver enzymes, constipation, headache, fatigue and nausea.
National Cancer Institute's report shows that breast cancer is the second highest
incidence of female mortality in the United States. In 2013, it was estimated that
some 232,340 women would be diagnosed with breast cancer and 39,620 patients died
of the disease. World Health Organization says breast cancer is the most common
female cancer in the world.
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