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使用荧光膀胱镜检测膀胱癌

By LabMedica International staff writers
Posted on 02 Mar 2010
一种用于光力学诊断系统、检测无创性乳头状膀胱癌的药物已经获得美国监管机构的积极回应。Hexvix(hexaminolevulinate)是一种正在开发的新药物,它可通过使用荧光膀胱镜来检测乳头状膀胱癌。

美国食品药物管理局(FDA)已经通知Photocure(Oslo, Norway; www.photocure.com),用于检测无创性乳头状膀胱癌的Hexvix新药申请有可能得到批准,其条件是得到Karl Storz(Tuttlingen, Germany; www.karlstorz.com)光力学诊断系统PMA(售前批准),并且Photocure和美国食品药物管理局在有关标签和售后承诺方面达到最终一致。这种光力学诊断系统是蓝光膀胱镜系统,将在美国市场上与Hexvix联合使用。Photocure预计在2010年上半年将与美国食品药物管理局就有待解决的问题达成一致。

Hexaminolevulinate在欧盟销售的商品名称为Hexvix。目前正以与美国食品药物管理局讨论在美国销售时将使用的名称。

Photocure在2009年6月30号递交了新药申请,并在2009年8月获得优先审批。新药申请包括一项关键性和四项支持性三期研究结果。对814位病人的关键性三期研究表明,对疑似患有无创乳头状膀胱癌的病人使用Hexvix膀胱镜比标准白光膀胱镜可显著提高检测率(p = 0.001)。检测率提高后可在随后9个月中显著降低复发率(p = 0.026)。所有支持性三期研究确认使用Hexvix可提高检测结果。

GE医疗公司(Chalfont St. More...
Giles, UK; www.gehealthcare.com)在2006年从Photocure获得了在全球销售和批发Hexvix的权利。Photocure将根据与GE医疗公司的协议,当新药申请和医疗装置PMA得到批准时获得阶段性付款。这里所说的医疗装置是指Karl Storz, GmbH的蓝光膀胱镜系统。美国食品药物管理局正在审核该系统的PMA。

Photocure的总裁兼首席执行官Kjetil Hestdal评论说:"我们非常高兴美国食品药物管理局确认在医疗中的确需要改善对膀胱癌的检测。我们相信这种新产品将在膀胱癌的诊断和管理中给病人带来显著的益处。在欧洲,自2005年获得批准后,超过五万七千病人已经使用了Hexvix药物。我们期待着得到美国食品药物管理局的批准,并随后在美国市场由GE医疗公司发布该产品。"

从全球来看,按照造成死亡的最常见癌症排列,膀胱癌在男性中占第四位,在女性中占第八位。随着目前工业化、生活方式因素和人口老龄化的发展,预计膀胱癌的发病率将继续上升。

膀胱癌的风险因素包括年龄、抽烟、职业(工作场所的致癌物)、感染、饮用砷污染的水、白种人、男性、家庭历史、使用化疗或放疗、饮用水过少、以及个人病史。膀胱癌的常见症状包括尿液中带血(使得尿液呈现略微铁锈颜色至深红色)、排尿时疼痛、尿频、或感到需要排尿却没有尿液。

Related Links:

Photocurewww.photocure.com
Karl Storz
www.karlstorz.com
GE Healthcare
www.gehealthcare.com

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