Phase III clinical success of Bayer anticancer drug Stivarga hepatocellular carcinoma
May 10, 2016 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Bayer anticancer drug Stivarga has recently obtained positive data in key phase III clinical trials and is expected to include hepatocellular carcinoma on the list of indications. Stivarga is an oral multi-kinase inhibitor that inhibits the activity of various important kinases such as VEGFR 1-3, KIT, RET, PDGFR and FGFR in tumorigenesis and has been approved in several tumors.
The phase III clinical trial data, called RESORCE, showed that Stivarga (regorafenib) significantly prolonged the overall survival of patients with hepatocellular carcinoma who were inoperable and who had previously undergone excessive treatment with soda (solafenib) but continued to worsen. Nexavar (Solafini) is also an anticancer drug developed and marketed by Bayer and has been approved in liver cancer.
Stivarga has been approved in colorectal cancer and gastrointestinal stromal tumors. It should have been a well-sold drug. However, due to the fierce competition in anticancer drugs in the US market, Stivarga's sales in the first quarter of this year have decreased. 24%. In the first quarter of this year, Stivarga's overall sales were 67 million euros, a decrease of 40 million euros compared with last year. If it can be approved in hepatocellular carcinoma, it will play a positive role in promoting the market share of Stivarga.
At the same time, in the next few months, Bayer will work hard to find opportunities to promote the drug's listing in Germany. After all, Germany is Europe's largest market.
Joerg Moeller, head of Bayer's pharmaceutical division, said that there is still no effective treatment for hepatocellular carcinoma, and Stivarga is expected to be the second systemic drug for hepatocellular carcinoma after sorafenib. Nexavar (Sorafenib) is an oral multi-targeting anticancer drug that has been approved for indications such as liver cancer, kidney cancer, and thyroid cancer. The current sales of Nexa (Solafini) is still growing rapidly, with sales in the first quarter increasing by 10% year-on-year to 213 million euros. Nexavar (Sorafenib) is by far the only FDA-approved systemic treatment for hepatocellular carcinoma.
Hepatocellular carcinoma has a poor prognosis, and although current treatments are progressing, the average overall survival of patients is still only 7 to 11 months. Bayer said it will submit the Phase III clinical trial data called RESORCE by the end of this year as an important basis for the Stivarga listing application for the treatment of patients with inoperable hepatocellular carcinoma.
Hepatocellular carcinoma is the most common type of liver cancer, and about 70-85% of liver cancer cases worldwide are hepatocellular carcinoma. Liver cancer is the sixth most common cancer in the world and the second most common type of cancer. China is a country with high incidence of hepatocellular carcinoma, and there is still no effective drug. If Stivarga is approved, it will hope to benefit this cancer patient.
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