（膽管癌）美國FDA接受YELIVA申請孤兒用藥
（膽管癌）美國FDA接受YELIVA申請孤兒用藥
Medical Supporter 資訊聲明
本文為國際醫療資訊整理，非醫療建議，無法取代主治醫師之診斷與治療方針。本站所載之醫療技術、藥物資訊與臨床數據，均編譯自日本各大醫療機關之公開文獻與官方說明；各項療法之適用性與成效受患者個人體質、病期與醫師診斷而異，須由合格醫師個別評估。
（膽管癌）美國FDA接受YELIVA申請孤兒用藥
- 2017年5月31日
- 讀畢需時 2 分鐘
膽管癌新藥資訊：
RedHill Biopharma(RDHL)公司於四月四號宣布美國FDA通過YELIVA(ABC294640)為罕見疾病用藥申請（僅為通過申請，但還未能夠上市），又被稱為孤兒藥認可，預計通過後用於膽管癌。（有些罕見疾病，由於市場規模相對小，藥商相對不會投入過多經費進去研究。）為了促進藥商重視這個領域，因此給予稅收抵免，減免處方藥用戶費用，該新聞稿指出，若後續順利獲准上市，可以獲得七年排他性銷售權。根據該公司新聞稿節錄重點表示：
膽管癌在術後恢復狀況不好，膽管癌患者的五年存活率約為2~30%之間。根據pahse1顯示，一共做了三例膽管固體腫瘤的晚期患者，其中一例PR，兩例為SD。目前正在進行phase 1/2的臨床，接受到NCI(National Cancer Institute)，Apogee公司和美國數所大學的支持。
YELIVA是一種口服的SK2抑制劑，具有抗癌和消炎功效。
該新聞稿很NICE的幫大家把文章的重點先整理出來了，請參考下面的原文，出處連結在下方。
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Orphan Drug designation allows RedHill to benefit from various development incentives to develop YELIVA®(ABC294640) for cholangiocarcinoma, as well as a seven-year marketing exclusivity period for the indication, if approved for marketing
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A Phase IIa clinical study with YELIVA® in patients with advanced, unresectable, intrahepatic and extrahepatic cholangiocarcinoma is planned to be initiated in the third quarter of 2017
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Cholangiocarcinoma (bile duct cancer) is a highly lethal malignancy for which there is a strong need for more effective systemic treatments; the 5-year relative survival rate for patients with cholangiocarcinoma ranges between 2% to 30%, depending on the tumor type and stage at diagnosis
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A Phase I study with YELIVA® in patients with advanced solid tumors successfully met its primary and secondary endpoints; of the three cholangiocarcinoma patients in the Phase I study, one patient had a sustained partial response and the other two had prolonged stable disease
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RedHill is pursuing several Phase I/II clinical studies with YELIVA®, targeting multiple oncology and inflammatory indications, some of which are supported by National Cancer Institute (NCI) grants awarded to Apogee Biotechnology and U.S. universities
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YELIVA® is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, with anti-cancer and anti-inflammatory activities
公司新聞稿，更詳細內容請參考：http://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=1365&PID=0&IID=5106
#膽管癌
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