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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗癌药物->治疗肺癌药物
处方药:处方药
包装规格: 150毫克/胶囊 70胶囊/盒
计价单位:
   
生产厂家中文参考译名:
诺华
生产厂家英文名:
 Novartis
该药品相关信息网址1:
 http://www.us.ceritinib.com/health-care-professional/index.jsp?site=PCAoAeyZdw&source=01030&irmasrc=CERWB0004&usertrack.filter_applied=true&NovaId=2935376979262948101
 原产地英文商品名:
 Zykadia HGC 150mg 70 capsules
原产地英文药品名:
 CERITINIB
中文参考商品译名:
 Zykadia HGC 150毫克/胶囊 70胶囊/盒
中文参考药品译名:
 色瑞替尼
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
 Lung cancer
 临床试验期:
 完成
中文适应病症参考翻译1:
 肺癌
药品信息:
商品名：Zykadia 通用名：ceritinib 曾用名：LDK378 适应证和用途 ZYKADIA是一种激酶抑制剂适用为对克唑替尼[crizotinib]治疗后已进展或不能耐受的间变性淋巴瘤激酶(ALK)-阳性转移非小细胞肺癌(NSCLC)患者的治疗。这个是一种是在根据肿瘤反应率和反应时间在加速批准下被批准的。尚未确定生存或疾病-相关症状改善。可能依验证性试验临床获益证实和描述情况而确定继续批准这个适应证。 剂量和给药方法 每天1次口服750mg。空腹给予ZYKADIA(即，不要餐后2小时内给予)。 剂型和规格 胶囊：150mg 禁忌证 无 警告和注意事项 ⑴ 严重和持续胃肠道毒性：在38%患者由于发生腹泻，恶心，呕吐或腹痛调整剂量。如止抗吐药或止泻药无反应不给药，然后减低ZYKADIA剂量。 ⑵ 肝毒性：ZYKADIA可能致肝毒性。至少每月监查肝实验室检验。不给药然后减低剂量，或永久终止ZYKADIA。 ⑶ 间质性肺疾病(ILD)/肺炎：在4%患者中发生。在被诊断有治疗相关ILD/肺炎患者中永久终止 ZYKADIA。 ⑷QT间期延长：ZYKADIA可能致QTc间期延长。监视心电图和电解质 in患者有充血性心脏衰竭，缓慢性心律失常，电解质异常，或患者正在用药物已知延长QTc间期。不给药然后减低剂量，或永久终止ZYKADIA。 ⑸ 高血糖：ZYKADIA可能致高血糖。监视葡萄糖和如指示开始或优化抗高血糖药物。不给药然后减低剂量，或永久终止ZYKADIA。 ⑹ 心动过缓：ZYKADIA可能致心动过缓。定期监视心率和血压。不给药然后减低剂量，或永久终止ZYKADIA。 ⑺ 胚胎胎儿毒性：ZYKADIA可能致胎儿危害。忠告有生殖潜能女性对胎儿潜在风险。 不良反应 最常见不良反应(发生率至少25%)为腹泻，恶心，转氨酶升高，呕吐，腹痛，疲乏，食欲减退，和便秘。 药物相互作用 ⑴ CYP3A抑制剂和诱导剂：避免ZYKADIA与强CYP3A抑制剂或诱导剂的同时使用。如不可避免同时使用某种强CYP3A抑制剂，减低ZYKADIA的剂量。 ⑵ CYP3A和CYP2C9底物：避免ZYKADIA 与有狭窄治疗指数的CYP3A或CYP2C9底物同时使用。 药企：诺华 FDA approves Zykadia for late-stage lung cancer Breakthrough therapy drug approved four months ahead of review completion goal date The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC). Zykadia is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients with metastatic ALK-positive NSCLC who were previously treated with crizotinib, the only other approved ALK tyrosine kinase inhibitor. Lung cancer is the leading cause of cancer-related deaths among men and women. According to the National Cancer Institute, an estimated 224,210 Americans will be diagnosed with lung cancer, and 159,260 will die from the disease this year. About 85 percent of lung cancers are NSCLC, making it the most common type of lung cancer. However, only 2-7 percent of patients with NSCLC are ALK-positive. “Today’s approval illustrates how a greater understanding of the underlying molecular pathways of a disease can lead to the development of specific therapies aimed at these pathways,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug eva luation and Research. “It also demonstrates the FDA’s commitment to working cooperatively with companies to expedite a drug’s development, review and approval, reflecting the promise of the breakthrough therapy designation program.” Zykadia is the fourth drug with breakthrough therapy designation to receive FDA approval. It is being approved four months ahead of the product’s prescription drug user fee goal date of Aug. 24, 2014, the date the agency was scheduled to complete review of the drug application. The FDA granted Zykadia breakthrough therapy designation, priority review and orphan product designation because the sponsor demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies; the drug had the potential, at the time of the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition; and the drug is intended to treat a rare disease, respectively. The FDA is approving Zykadia under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. Zykadia’s safety and effectiveness were established in a clinical trial of 163 participants with metastatic ALK-positive NSCLC. All participants were treated with Zykadia. Results showed that about half of the participants had their tumors shrink, and this effect lasted an average of about seven months. Common side effects of Zykadia include gastrointestinal symptoms such as diarrhea, nausea, vomiting and abdominal pain. Laboratory abnormalities such as increased liver enzymes, pancreatic enzymes and increased glucose levels were also observed. Zykadia is marketed by Novartis, based in East Hanover, N.J. For more information: FDA: Office of Hematology and Oncology Products FDA: Approved Drugs: Questions and Answers FDA: Drug Innovation FDA: Breakthrough Therapies NCI: Lung Cancer
更新日期: 2015-03-31
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