Sanwei's new anti-cancer drug Halaven China Breast Cancer Phase III clinically successful, submitted a new drug application to CFDA in the first half of the year
May 25, 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)];Eisai, a Japanese pharmaceutical company, recently announced that a phase III clinical trial of breast cancer (Study 304) on the new anticancer drug Halaven (eribulin mesylate). The study was conducted in women with locally recurrent or metastatic breast cancer in China. Data showed that progression-free survival (PFS) was statistically significant in the Havalen-treated group compared with the anti-neoplastic vinorelbine-treated group. Significant improvement, reaching the primary endpoint of the study. In terms of safety, the most common adverse events in the Halaven treatment group included central neutropenia, anemia, fever, and fatigue, which are consistent with the side effects known to Halaven.
Study 304 is a multicenter, open-label, randomized, parallel group phase III study in China involving 530 women with locally recurrent or metastatic breast cancer who have received at least 2 and up to 5 previously Treatment with chemotherapy regimens (including anthracyclines and taxanes) compared Havalen with vinorelbine for efficacy and safety. The primary endpoint was progression-free survival (PFS). Detailed results of the study have been submitted to the upcoming academic conference.
Based on the results of the study, Eisai plans to submit a new drug application (NDA) for Havalen treatment of breast cancer to the China State Food and Drug Administration (CFDA) in the first half of 2016.
In recent years, confirmed cases of breast cancer have been steadily increasing in China. It is estimated that 272,400 cases of invasive breast cancer will be added in 2015, with 70,700 deaths. Currently, breast cancer is the most common type of cancer diagnosis among Chinese women.
Havalen is a synthetic halichondrin B analogue, a microtubule dynamics inhibitor with a novel mechanism of action. Halichondrin B is a substance found on black sponges growing along the coast of Japan, which can effectively cure tumors. Founded and developed by Eisai, Havalen is the only single-agent chemotherapy drug that was first approved by the FDA for the treatment of metastatic breast cancer in 2010. Currently, Halaven has been approved by more than 60 countries around the world, including Japan, Europe, the United States, and Asia.
Recent non-clinical studies have shown that Halaven is associated with increased vascular perfusion and permeability in the core area of ​​the tumor. Halaven improves epithelial cell status and reduces the ability of breast cancer cells to migrate. In the first half of this year, Halaven was approved by the United States, Japan, and the European Union for unresectable or metastatic liposarcoma (STS).
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