XALKORI（通用名：crizotinib capsule，克里唑蒂尼胶囊）

	授权形式：	免费版	作者/开发商：
	文件大小：	16.78 Kb	解压密码：
	软件语言：	简体中文	更新时间：	2012-05-15
	版本号：	1.0	软件平台：	Win2000/WinXP/Win2003
	软件类别：	国产软件	演示地址：
	评分等级：	★★★★★	注册地址：
	发布人：	admin	下载次数：	4（今日：4，本周：4，本月：4）
	插件认证：	无插件	浏览次数：	219

本地下载： 下载地址

部分中文Xalkori处方资料（仅供参考）

2011年8月26日，辉瑞公司的XALKORI®(crizotinib)胶囊获得美国食品药品管理局(FDA)批准，这是第一个对间变性淋巴瘤激酶 (ALK)进行靶向治疗的药品，用于治疗通过FDA批准的检测方法诊断为ALK阳性的局部晚期或转移的非小细胞肺癌 (NSCLC) .
2011年8月至2012年3月期间FDA批准的呼吸科新药盘点：

1.XALKORI：治疗ALK阳性的局部晚期或转移的非小细胞肺癌 (NSCLC)

XALKORI （通用名：crizotinib capsule，克里唑蒂尼胶囊）

2011年8月26日，辉瑞公司的XALKORI®(crizotinib)胶囊获得美国食品药品管理局(FDA)批准，这是第一个对间变性淋巴瘤激酶 (ALK)进行靶向治疗的药品，用于治疗通过FDA批准的检测方法诊断为ALK阳性的局部晚期或转移的非小细胞肺癌 (NSCLC) 。

XALKORI(crizotinib)是一种口服酪氨酸激酶受体遏抑剂。Crizotinib的分子式是C21H22Cl2FN5O。

适应证和用途：XALKORI是一种激酶抑制剂适用于有局部晚期或转移非小细胞肺癌(NSCLC)患者的治疗是当用一种FDA批准的检验变性淋巴瘤激酶(ALK)-阳性。 这个适应症是基于反应率。没有可以得到的资料显示用XALKORI报道患者的结局或生存改善。

剂量和给药方法：（1）250 mg口服每天2次有或无食物。（2）根据个体安全性和耐受性可能需要给药中断和/或剂量减低至200 mg口服每天2次，然后如需要进一步减低至250 mg口服每天1次。

剂型和规格：XALKORI胶囊： 250 mg和200 mg。

禁忌证：无

警告和注意事项：

（1）肺炎：严重，包括致命性，治疗-相关肺炎曾观察到。为指示性肺炎肺部症状监视患者。有治疗-相关肺炎诊断患者中永远终止。

（2）肝实验室异常：曾发生ALT和总胆红素同时升高。每月监视和当临床指示有2-4级升高患者用更频繁检验。当指示，暂时停止，减低剂量，或永远终止XALKORI。

（3）QT间隔延长：有病史或QTc延长倾向患者，或服用已知延长QT间隔药物， 应考虑监视心电图定期和电解质。

（4）ALK检验：为选择用ALKORI治疗患者需要用一种FDA批准的检验检测ALK-阳性NSCLC，适用于这个用途。

（5） 妊娠：当给予妊娠妇女时XALKOR可能致胎儿危害。

不良反应：最常见不良反应(≥25%)是视力障碍，恶心，腹泻，呕吐，水肿，和便秘

处方药:处方药

包装规格: 250毫克/胶囊 60胶囊/瓶

生产厂家中文参考译名:辉瑞

生产厂家英文名:PFIZER

FDA NEWS RELEASE
For Immediate Release: Aug. 26, 2011
Media Inquiries: Erica Jefferson, 301-796-4988
Consumer Inquiries: 888-INFO-FDA

FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer
Second targeted therapy approved with a test this year

The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.

Xalkori is being approved with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene, a first-of-a-kind genetic test called the Vysis ALK Break Apart FISH Probe Kit. It is the second such targeted therapy approved by the FDA this year.

This ALK gene abnormality causes cancer development and growth. About 1 percent to 7 percent of those with NSCLC have the ALK gene abnormality. Patients with this form of lung cancer are typically non-smokers. Xalkori works by blocking certain proteins called kinases, including the protein produced by the abnormal ALK gene. Xalkori is a pill taken twice a day as a single-agent treatment.

“The approval of Xalkori with a specific test allows the selection of patients who are more likely to respond to the drug” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug eva luation and Research. “Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects.”

Xalkori’s safety and effectiveness were established in two multi-center, single-arm studies enrolling a total of 255 patients with late-stage ALK-positive NSCLC. A sample of a patient’s lung cancer tissue was collected and tested for the ALK gene abnormality prior to study enrollment. The studies were designed to measure objective response rate, the percentage of patients who experienced complete or partial cancer shrinkage. Most patients in the studies had received prior chemotherapy.

In one study, the objective response rate was 50 percent with a median response duration of 42 weeks. In another, the objective response rate was 61 percent with a median response duration of 48 weeks.

The FDA based its approval of the Vysis ALK Break Apart FISH Probe Kit on data from one of the studies.

Xalkori was reviewed under the FDA’s priority review program, which provides for an expedited six-month review of drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists.

Xalkori is being approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients. The program is designed to provide patients with earlier access to promising new drugs, followed by further studies to confirm the drug’s clinical benefit.

Xalkori and the companion Vysis ALK Break Apart FISH Probe Kit were approved ahead of the drug’s Sept. 30, 2011, FDA review goal date and the companion diagnostics’ Sept. 28, 2011, review goal date.

“The trend in oncology research continues towards targeted therapies,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device eva luation and Safety in the FDA’s Center for Devices and Radiological Health. “This test is an example of the important role companion diagnostics play in determining that the safest and most effective treatments are promptly delivered to patients living with serious and life-threatening diseases.”

The most common side effects reported in patients receiving Xalkori included vision disorders, nausea, diarrhea, vomiting, swelling (edema), and constipation. Vision disorders included visual impairment, flashes of light, blurred vision, floaters, double vision, sensitivity to light, and visual field defects. Xalkori use has also been associated with inflammation of the lung tissue (pneumonitis), which can be life-threatening. Patients with treatment-related pneumonitis should permanently stop treatment with Xalkori. The drug should not be used in pregnant women.

In July 2011, FDA issued a draft guidance industry on the agency’s policy for reviewing a companion diagnostic and the corresponding drug therapy. The guidance is currently available for public comment.

Xalkori is marketed by New York City-based Pfizer. The Vysis ALK Break Apart FISH Probe Kit is marketed by Abbott Molecular Inc. of Des Plaines, Ill.