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China's FDA Approves Nexavar For Liver Cancer Treatment

Armen Hareyan's picture
Nexavar Approved For Liver Cancer Treatment in China

Nexavar becomes the latest and newest approved treatment for liver cancer in China. Nexavar is made by Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals and received approval by China's State Food and Drug Administration (SFDA) for liver cancer treatment.

Nexavar (sorafenib) is the first and the only approved pill for unresectable or metastatic hepatocellular carcinoma, which are the most common forms of liver cancer treatment. The drug is approved for advanced kidney cancer treatment in 70 countries. It is also approved as liver cancer treatment in 40 countries and now it comes to Chine. Bayer and Onyx plan to apply the drug for approval as breast and lung cancer treatment as well.

Hepatocellular carcinoma accounts for 90% of all liver cancer cases affecting more than 600,000 people annually worldwide. China has the highest number of liver cancer sufferers - 340,000 cases a year. South Korea, Japan and Taiwan together report about 600,000 new cases annually, European counties report 54000 cases, US reports 15000 cases. The number of people affected by liver cancer increase each year, especially in China, this is why Nexavar approval is extremely important for China.

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In 2002, liver cancer killed 600,000 people worldwide, out of which 370,000 deaths occurred in China, South Korea and Japan, while European Union saw 57,000 deaths, and United States reported 13,000 deaths.

Bayer and Onyx conducted two Phase 3 clinical trials involving 800 patients, who did not receive any treatment before the study begun. Nexavar was able to effectively target the most important processes in cancer - cell proliferation (growth) and angiogenesis (blood supply).

"This is another significant milestone in a region where patients are in dire need of a therapy that improves survival," said N. Anthony Coles, MD, president and chief executive officer, Onyx Pharmaceuticals, Inc. "The approval in liver cancer in China comes less than two years after the approval in advanced kidney cancer and proves that Nexavar is and will continue to be an important foundational therapy in multiple patient populations."

This is how Nexavar treats cancer. Bayer says "Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth."