(膽管癌)美國FDA接受YELIVA申請孤兒用藥


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。

* 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

* 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

* 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

* 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

* 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

* 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

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