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新闻提要

FDA于当地时间2016年3月11日批准将克唑替尼（赛可瑞）适应证扩展到含有ROS-1基因突变的转移性患者。克唑替尼成为第一个FDA批准用于ROS-1阳性NSCLC患者的治疗药物，也是FDA唯一批准的针对ROS-1和ALK两类不同分子靶点的靶向药物。

FDA Release

The U.S. Food and Drug Administration today approved Xalkori 赛可瑞**(crizotinib** 克唑替尼**）**to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. Xalkori is the first and only FDA approved（批准的） treatment for patients with ROS-1 positive NSCLC.

Lung cancer is the leading（首要的，主要的） cause of cancer-related deaths in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. ROS-1 gene alterations, thought to lead to abnormal cells, have been identified in various cancers, including NSCLC. ROS-1 gene alterations（基因突变，也可用gene mutation) are present in approximately 1 percent of patients with NSCLC. The overall patient and disease characteristics of NSCLC with ROS-1 gene alterations appear similar to NSCLC with anaplastic lymphoma kinase (ALK，间变性淋巴瘤激酶) gene alterations, for which crizotinib use was previously approved. Xalkori was approved to treat certain patients with late-stage NSCLC that expresses an abnormal ALK gene in 2011.

“Lung cancer is difficult to treat, in part, because patients have different mutations, some of which are rare,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The expanded use of Xalkori will provide a valuable treatment option for patients with the rare and difficult to treat ROS-1 gene mutation by giving health care practitioners a more personalized way of targeting ROS-1 positive NSCLC.”

Xalkori is an oral medication that blocks the activity of the ROS-1 protein in tumors that have ROS-1 gene alterations. This effect on ROS-1 may prevent NSCLC from growing and spreading.

The safety and efficacy of Xalkori for the treatment of patients with ROS-1 positive tumors were evaluated in a multi-center, single-arm study of 50 patients with ROS-1 positive metastatic NSCLC. Patients received Xalkori twice daily to measure the drug’s effect on their lung cancer tumors. The studies were designed to measure overall response rate, the percentage of patients who experienced complete or partial shrinkage of their tumors. Results showed 66 percent of participants experienced a complete or partial shrinkage of their NSCLC tumors, an effect that lasted a median of 18.3 months.

The safety results of this study were generally consistent with the safety profile of Xalkori evaluated in 1,669 patients with ALK-positive metastatic（转移性的） NSCLC.

The most common side effects of Xalkori are vision disorders, nausea, diarrhea, vomiting, swelling (edema****水肿), constipation（便秘）, liver problems (elevated transaminases), fatigue, decreased appetite, upper respiratory infection, and dizziness and numbness or tingling in the hands or feet (neuropathy)（该句有12个表示症状的词和短语）. Xalkori may cause serious side effects, including liver problems, life-threatening or fatal inflammation of the lungs, abnormal heartbeats and partial or complete loss of vision in one or both eyes.

The FDA granted the Xalkori expanded use application breakthrough（重大突破，突破性进展） therapy designation and priority review status. These are distinct programs intended to facilitate and expedite（expedite这个词的意思是“促进，加快”，建议大家把这个词收了） the development and review of certain new drugs in light of their potential to benefit patients with serious or life-threatening conditions. Xalkori also received orphan drug（孤儿药，用了治疗罕见病的药物） designation, which provides incentives（动机，刺激）such as tax credits, user fee waivers（弃权，放弃） and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.

Xalkori is marketed by Pfizer, based in New York, New York.

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 ( 兽医，兽医的） drugs, vaccines（疫苗） and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics（化妆品）, dietary supplements（膳食补充剂）, products that give off（释放） electronic radiation（辐射）, and for regulating tobacco products.

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