重磅！FDA批准新药Alecensa（alectinib）治疗ALK阳性非小细胞肺癌

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美国食品和药物管理局（FDA）近日批准基因泰克的新药 Alecensa (alectinib) 来治疗患有晚期（转移性）ALK阳性非小细胞肺癌（NSCLC），这些患者在使用Xalkori (crizotinib，克唑替尼)治疗后疾病进展或不耐受该治疗。

FDA批准新药Alecensa治疗ALK阳性非小细胞肺癌



FDA approves new oral therapy to treat ALK-positive lung cancer

The U.S. Food and Drug Administration today approved Alecensa (化学名称alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib).

Alecensa (alectinib口服新药)是一种有效的ALK抑制剂。用于治疗Crizotinib治疗失败的晚期 转移性ALK阳性非小细胞肺癌 (NSCLC) 。目前在美国和日本已上市，患者咨询Alecensa (alectinib）请登录全球肿瘤医生网或拨打电话：.

美国食品和药物管理局（FDA）近日批准基因泰克的新药 Alecensa (alectinib) 来治疗患有晚期（转移性）ALK阳性非小细胞肺癌（NSCLC），这些患者在使用Xalkori (crizotinib，克唑替尼)治疗后疾病进展或不耐受该治疗。

Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. An ALK (anaplastic lymphoma kinase) gene mutation can occur in several different types of cancer cells, including lung cancer cells. ALK gene mutations are present in about 5 percent of patients with NSCLC. In metastatic cancer, the disease spreads to new parts of the body. In ALK-positive NSCLC metastatic patients, the brain is a common place for the disease to spread.

肺癌是美国癌症病人的头号杀手，在2015年大约有221,200名新增的肺癌患者，并导致158,040人死亡。ALK (间变性淋巴瘤激酶) 基因突变可以出现在几种不同类型的癌细胞上，包括肺癌细胞。5%左右的非小细胞肺癌患者出现ALK基因突变。转移癌疾病会扩散到身体的新部位。在ALK阳性转移性非小细胞肺癌的患者，疾病都会扩散到大脑。

Todays approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with Xalkori, said Richard Pazdur, M.D., director of the Office of Hematology and oncology Products in the FDAs Center for Drug evaluation and Research. In addition to the primary effect on tumors in the lung, Alecensa clinical trials provide evidence of an effect on tumors that had spread to the brain, which is an important effect for clinicians to understand.

克唑替尼治疗失败的患者很少能找到其它合适的治疗，今天的批准的Alecensa为克唑替尼治疗失败的患者提供了一种新的治疗药物,FDA药物评价和研究中心血液学和肿瘤产品办公室的主任，Richard Pazdur博士说：临床试验证明，Alecensa不仅对肺部肿瘤起的很大作用, Alectinib对扩散到脑部的肿瘤也有作用, 这是需要临床医生理解的一个很大的不同。

Alecensa is an oral medication that blocks the activity of the ALK protein, which may prevent NSCLC cells from growing and spreading.

Alecensa是一种口服药物，可以阻断ALK蛋白，从而防止非小细胞肺癌细胞生长和扩散。

The safety and efficacy of Alecensa were studied in two single-arm clinical trials of patients with metastatic ALK-positive NSCLC whose disease was no longer controlled by treatment with Xalkori. Study participants received Alecensa twice daily to measure the drugs effect on their lung cancer tumors. In the first study, 38 percent of participants experienced a partial shrinkage of their NSCLC tumors, an effect that lasted for an average of 7.5 months. In the second study, 44 percent of participants experienced a partial shrinkage of their NSCLC tumors, lasting for an average of 11.2 months. The trials also examined Alecensas effect on individuals brain metastases, a common occurrence in this population. Sixty-one percent of participants in the two trials who had measurable brain metastases experienced a complete or partial reduction in their brain tumors, lasting an average of 9.1 months.

Alecensa的安全性和有效性是通过两个单臂临床试验证明的，患者患有转移性ALK阳性非小细胞肺癌，使用克唑替尼失败后，参加此临床试验。研究参与的患者每天两次收到Alecensa，来衡量他们的肺癌肿瘤药物的治疗效果。在第一个临床试验中，一天两次的药使87名参与者的38%肺肿瘤缩小，这一效果持续了平均7.5半月。在第二个临床试验中，138名患者中44%的患者肿瘤缩小了，这一效果持续了平均大约11.2个月。两个临床研究也都测试了Alecens对已经扩散到大脑的肿瘤治疗效果，在这类病人中这种肿瘤转移经常发生。根据FDA的结果，两项研究中61%的患者脑部肿瘤缩小或消失了，效果平均持续大约9.1个月。

The most common side effects of Alecensa are fatigue, constipation, swelling (edema) and muscle pain (myalgia). Alecensa may cause serious side effects, including liver problems, severe or life-threatening inflammation of the lungs, very slow heartbeats and severe muscle problems. Treatment with Alecensa may cause sunburn when patients are exposed to sunlight.

Alecensa的最常见的副作用是疲劳，便秘，浮肿（水肿）和肌肉疼痛（肌痛）。 Alecensa可能会导致严重的副作用，包括肝脏问题，肺部炎症，严重时或危及生命，心跳减慢和严重的肌肉问题。当患者暴露于阳光下，Alecensa治疗也可能导致晒伤。

Alecensa was approved using theaccelerated approvalregulatory pathway, which allows the FDA to approve products for serious or life-threatening diseases based on evidence that the product has an effect on an outcome that is reasonably likely to predict clinical benefit. In the case of Alecensa, the tumor response to treatment, along with the duration of response, provided this evidence. Under the accelerated approval requirements, a confirmatory study is required to verify and describe the clinical benefit of Alecensa.

Alecensa的获批是通过FDA的加速审批监管通道实现的，FDA的该途径对治疗严重或致命疾病的产品给予的特殊审批，这些产品在临床试验上的效果好。Alecensa治疗肿瘤的效果和持续时间提供了证据。根据加速审批要求，验证性研究需要证实并描述Alecensa的临床益处。

The FDA granted the Alecensa applicationbreakthrough therapy designationandpriority review status. These are distinct programs intended to facilitate and expedite the development and review of certain new drugs in light of their potential to benefit patients with serious or life-threatening conditions.Alecensa also receivedorphan drug designation, whichprovides incentives such as tax credits, user fee waivers and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.

FDA授予Alecensa突破治疗称号和优先审核资格。这些都是旨在促进和加速某些新药的开发和审批，以造福那些患有严重或危及生命的疾病的患者。

Alecensa还被授予孤儿药物，该条件提供相应的激励措施，比如税收抵免、用户费减免、市场独占资格，以协助和鼓励开发针对罕见疾病的药物。

Alecensa is marketed by Genentech, based in San Francisco, California. Xalkori is marketed by Pfizer, based in New York, New York.

Alecensa由总部设在加利福尼亚州旧金山市的基因泰克公司销售。Xalkori 是由美国纽约的辉瑞销售。

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

美国食品药品管理局 (简称FDA），隶属于美国卫生教育福利部，负责全国药品、食品、生物制品、化妆品、兽药、医疗器械以及诊断用品等的管理。

FDA批准的针对ALK阳性的肺癌药物统计：

2011年8月，FDA批准首个ALK阳性非小细胞肺癌的靶向治疗药物Xalkori (crizotinib，克唑替尼)，由美国辉瑞的生产。

2014年4月29日， FDA批准诺华制药ceritinib用于转移性非小细胞肺癌治疗



口服药ceritinib色瑞替尼是FDA批准的第二个ALK抑制剂。

2015年12月11日FDA批准基因泰克的新药 Alecensa (alectinib) 用于治疗Crizotinib治疗失败的晚期（转移性）ALK阳性非小细胞肺癌。

原文题目：FDA approves new oral therapy to treat ALK-positive lung cancer

原文链接：http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476926.htm

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