FDA扩大了Stivarga的批准，以纳入肝癌

StephenW

FDA expands approval of Stivarga to include liver cancer
April 27, 2017

The FDA expanded the approval of regorafenib to include the treatment of patients with hepatocellular carcinoma who have been treated with sorafenib.

  
Regorafenib (Stivarga, Bayer) - a kinase inhibitor that works times blocking several enzymes that promote cancer growth - is the first FDA-approved treatment for liver cancer in nearly a decade.

A randomized trial based the safety and efficacy of regorafenib vs. placebo in 573 patients with HCC's historical as haded after receiving sorafenib (Nexavar, Bayer).

(3.1 vs vs. months) and overall response rate (11% vs. 4%) compared with patients treated with placebo.

"Limited treatment options are available for patients with liver cancer," Richard Pazdur, MD, acting director of the office of hematology and oncology products in the FDA's Center for Drug Evaluation and Research and director of the FDA's Oncology Center of Excellence, said in a Press release. "This is the first time patients with HCC have had an FDA-approved treatment that can be used if their cancer has no circumstances to respond to initial treatment with sorafenib."

Common fever events include pain, hand-foot skin reaction, fatigue, diarrhea, decreased appetite, high blood pressure, infection, difficulty speaking, high levels of bilirubin in the blood, fever, inflammation of the mucous membranes, weight loss, rash and nausea The

The FDA warned regorafenib is associated with serious risks, including liver damage, infections, heavy bleeding, holes in the stomach or intestines, skin damage, hypertension, problems with blood flow to the heart, temporary brain swelling and wound complications complications

This application had been granted priority review and orphan drug designation. Regorafenib also is indicated for colorectal cancer and gastrointestinal stromal tumors that are no longer cases

StephenW

FDA扩大了Stivarga的批准，以纳入肝癌
2017年4月27日

FDA扩大了regorafenib的批准，包括用索拉非尼治疗的肝细胞癌患者的治疗。


Regorafenib（Stivarga，Bayer） - 一种激酶抑制剂，其作用是阻止几种促进癌症生长的酶 - 是近十年来首例通过FDA批准的肝癌治疗。

一项随机试验，其基于安慰和安慰剂的疗效，其中573例接受索拉非尼（Nexavar，Bayer）治疗HCC历史的病人。

（3.1 vs vs月）和总体反应率（11％vs. 4％）相比，安慰剂治疗组。

FDA的药物评估和研究中心的血液学和肿瘤学产品办公室主任Richard Pazdur博士说：“有限的治疗方案适用于肝癌患者。新闻稿。 “这是HCC患者第一次获得FDA批准的治疗方案，如果癌症无法对索拉非尼进行初步治疗作出反应，可以使用。

常见的发烧事件包括疼痛，手脚皮肤反应，疲劳，腹泻，食欲降低，血压高，感染困难，血液中胆红素水平高，发热，粘膜炎，体重减轻，皮疹和恶心的

FDA警告说，regorafenib与严重的风险相关，包括肝损伤，感染，大量出血，胃或肠中的孔，皮肤损伤，高血压，血液流向心脏的问题，临时性脑肿胀和伤口并发症并发症

该申请已获得优先审查和孤儿药物指定。雷诺非尼也被指定为不再是病例的结肠直肠癌和胃肠道间质瘤