Jazz Pharmaceuticals Receives European Commission Approval for Ziihera® to Treat Advanced HER2-Positive Biliary Tract Cancer

Reuters

Jul 01, 2025

Jazz Pharmaceuticals Receives European Commission Approval for Ziihera® to Treat Advanced HER2-Positive Biliary Tract Cancer

Jazz Pharmaceuticals plc has announced that the European Commission has granted conditional marketing authorization for Ziihera® (zanidatamab) for the treatment of advanced HER2-positive biliary tract cancer $(BTC.AU)$. This authorization, based on positive results from the HERIZON-BTC-01 Phase 2b trial, marks a significant milestone as Ziihera becomes the first HER2-targeted therapy approved in the European Union specifically for this patient population. The approval applies to all EU Member States, as well as Iceland, Norway, and Liechtenstein. This development provides a new targeted monotherapy option for patients who have limited treatment alternatives and highlights the importance of HER2 testing in BTC to identify eligible patients for biomarker-driven treatments.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Jazz Pharmaceuticals plc published the original content used to generate this news brief via PR Newswire (Ref. ID: SF17992) on July 01, 2025, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

1
2
3
4
5
6
7
8
9
10

{"basename":"","ssrTDKData":{"titleTemplate":"%s - Tiger Brokers","title":"Tiger Brokers | Global Stocks, Options & Futures Trading App","description":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","keywords":"tiger brokers,tiger trade,tiger brokers singapore,broker online,stock trading in singapore,share trading singapore,brokerage firm singapore,trading app,stock broker singapore,stock trading platforms,trading account","social":{"ogDescription":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/news/2548254009"},"companyName":"Tiger Brokers"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2548254009\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2548254009?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-07-01 20:32","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2548254009","market":"nz","top_or_hot":-1,"title":"Jazz Pharmaceuticals Receives European Commission Approval for Ziihera® to Treat Advanced HER2-Positive Biliary Tract Cancer","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      Jazz Pharmaceuticals Receives European Commission Approval for Ziihera® to Treat Advanced HER2-Positive Biliary Tract Cancer\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Jazz Pharmaceuticals plc has announced that the European Commission has granted conditional marketing authorization for Ziihera® (zanidatamab) for the treatment of advanced HER2-positive biliary tract cancer <a href=\"https://laohu8.com/S/BTC.AU\">$(BTC.AU)$</a>. This authorization, based on positive results from the HERIZON-BTC-01 Phase 2b trial, marks a significant milestone as Ziihera becomes the first HER2-targeted therapy approved in the European Union specifically for this patient population. The approval applies to all EU Member States, as well as Iceland, Norway, and Liechtenstein. This development provides a new targeted monotherapy option for patients who have limited treatment alternatives and highlights the importance of HER2 testing in BTC to identify eligible patients for biomarker-driven treatments.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Jazz Pharmaceuticals plc published the original content used to generate this news brief via PR Newswire (Ref. ID: SF17992) on July 01, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Jazz Pharmaceuticals Receives European Commission Approval for Ziihera® to Treat Advanced HER2-Positive Biliary Tract Cancer</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nJazz Pharmaceuticals Receives European Commission Approval for Ziihera® to Treat Advanced HER2-Positive Biliary Tract Cancer\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2025-07-01 20:32</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      Jazz Pharmaceuticals Receives European Commission Approval for Ziihera® to Treat Advanced HER2-Positive Biliary Tract Cancer\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Jazz Pharmaceuticals plc has announced that the European Commission has granted conditional marketing authorization for Ziihera® (zanidatamab) for the treatment of advanced HER2-positive biliary tract cancer <a href=\"https://laohu8.com/S/BTC.AU\">$(BTC.AU)$</a>. This authorization, based on positive results from the HERIZON-BTC-01 Phase 2b trial, marks a significant milestone as Ziihera becomes the first HER2-targeted therapy approved in the European Union specifically for this patient population. The approval applies to all EU Member States, as well as Iceland, Norway, and Liechtenstein. This development provides a new targeted monotherapy option for patients who have limited treatment alternatives and highlights the importance of HER2 testing in BTC to identify eligible patients for biomarker-driven treatments.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Jazz Pharmaceuticals plc published the original content used to generate this news brief via PR Newswire (Ref. ID: SF17992) on July 01, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0889565916.HKD","symbol_name":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250701:nNDLb5mMrh:1","article_id":"2548254009","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2548254009","pubTimestamp":1751373121,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Jazz Pharmaceuticals plc has announced that the European Commission has granted conditional marketing authorization for Ziihera  for the treatment of advanced HER2-positive biliary tract cancer . This authorization, based on positive results from the HERIZON-BTC-01 Phase 2b trial, marks a significant milestone as Ziihera becomes the first HER2-targeted therapy approved in the European Union specifically for this patient population. The approval applies to all EU Member States, as well as Iceland, Norway, and Liechtenstein. This development provides a new targeted monotherapy option for patients who have limited treatment alternatives and highlights the importance of HER2 testing in BTC to identify eligible patients for biomarker-driven treatments.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should no","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","BK4532":"文艺复兴科技持仓","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","IE00BN0W2V16.EUR":"GUINNESS SUSTAINABLE GLOBAL EQUITY \"C\" (EUR) ACC","LU0823416689.USD":"BNP PARIBAS HEALTH CARE INNOVATORS \"C\" (USD) ACC","BK4533":"AQR资本管理(全球第二大对冲基金)","BK4007":"制药","IE00BN0W2T93.GBP":"GUINNESS SUSTAINABLE GLOBAL EQUITY \"C\" (GBP) ACC","JAZZ":"爵士制药","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","IE00BN0W2W23.USD":"GUINNESS SUSTAINABLE GLOBAL EQUITY \"C\" (USD) ACC"},"translate_title":"Jazz Pharmaceuticals的Ziihera获得欧盟委员会批准®治疗晚期HER2阳性胆道癌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"JAZZ":0.9},"content_text":"Jazz Pharmaceuticals Receives European Commission Approval for Ziihera® to Treat Advanced HER2-Positive Biliary Tract Cancer\n    \n\n        Jazz Pharmaceuticals plc has announced that the European Commission has granted conditional marketing authorization for Ziihera® (zanidatamab) for the treatment of advanced HER2-positive biliary tract cancer $(BTC.AU)$. This authorization, based on positive results from the HERIZON-BTC-01 Phase 2b trial, marks a significant milestone as Ziihera becomes the first HER2-targeted therapy approved in the European Union specifically for this patient population. The approval applies to all EU Member States, as well as Iceland, Norway, and Liechtenstein. This development provides a new targeted monotherapy option for patients who have limited treatment alternatives and highlights the importance of HER2 testing in BTC to identify eligible patients for biomarker-driven treatments.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Jazz Pharmaceuticals plc published the original content used to generate this news brief via PR Newswire (Ref. ID: SF17992) on July 01, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}