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Date: 2013-02-01 00:00:00Written By

拜耳向日本MHLW提交regorafenib上市许可申请

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键词:拜耳,regorafenib

 

2012年12月28日 讯 /生物谷BIOON/ --拜耳(Bayer)日本子公司Bayer Yakuhin宣布,已向日本卫生劳动福利部(MHLW)提交了regorafenib的上市许可申请(MAA),该药用于手术不能切除性晚期/复发性结直肠癌患者的治疗。

拜耳于今年7月向MHLW提交了regorafenib的新药申请,并于今年9月获得了优先审查资格。(生物谷bioon.com)

英文原文:
Bayer Yakuhin Ltd., the Japanese subsidiary of Bayer AG (BAYRY), submitted a marketing authorization application for regorafenib to the Ministry of Health, Labour and Welfare (:MHLW) in Japan.

Bayer is looking to get regorafenib approved for treating patients suffering from metastatic and/or unresectable gastrointestinal stromal tumors (:GIST). The company had earlier submitted a marketing application for the candidate in Japan for the treatment of colorectal cancer (CRC) and received priority review in August this year.

Bayer is seeking approval for regorafenib on the basis of encouraging data from a phase III study (GRID), which evaluated patients suffering from metastatic and/or unresectable GIST. The company conducted the phase III study across the globe including eight sites in Japan.
Bayer is looking for the US approval of regorafenib for the GIST indication. A decision from the US Food and Drug Administration (:FDA) should be out in February 2013.

We remind investors that in October this year, the FDA approved regorafenib, under the trade name of Stivarga, for treating patients suffering from metastatic colorectal cancer (mCRC). The company is also looking for EU approval of the drug in this indication.

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