Jazz and Zymeworks announce FDA approval of cancer therapy Ziihera

seekingalpha2024-11-21

GrandbrothersJazz Pharmaceuticals (NASDAQ:JAZZ) and Zymeworks (NASDAQ:ZYME) announced Thursday the FDA approval of their jointly developed bispecific antibody Ziihera as a late-line treatment for ...

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Specifically, according to the FDA's labeling information, Ziihera will be available in the U.S. for adults with previously treated, unresectable, or metastatic HER2-positive  biliary tract cancer whose disease status has been confirmed by an FDA-approved test. The agency has cleared Ziihera under its accelerated approval pathway, and the drug’s continued availability in the U.S. will depend on data from an confirmatory trial. The companies are advancing a global confirmatory trial called HERIZON-BTC-302 designed to test Ziihera plus standard of care versus standard of care alone as a first-line option for HER2-positive BTC. Zymeworks , Jazz’s  licensing partner for Ziihera  for regions including the U.S., is set to receive a $50M milestone payment as part of the approval. The ","collect":0,"end_time":0,"defaultTopTitle":"seekingalpha.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"JAZZ":"爵士制药","ZYME":"ZYMEWORKS INC (US)","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","BK4139":"生物科技","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","BK4007":"制药","BK4533":"AQR资本管理(全球第二大对冲基金)","BK4532":"文艺复兴科技持仓","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD"},"translate_title":"Jazz和Zymeworks宣布FDA批准癌症疗法Ziihera","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"JAZZ":0.9,"ZYME":0.9},"content_text":"GrandbrothersJazz Pharmaceuticals (NASDAQ:JAZZ) and Zymeworks (NASDAQ:ZYME) announced Thursday the FDA approval of their jointly developed bispecific antibody Ziihera as a late-line treatment for certain adults with biliary tract cancer. Specifically, according to the FDA's labeling information, Ziihera will be available in the U.S. for adults with previously treated, unresectable, or metastatic HER2-positive (IHC 3+) biliary tract cancer whose disease status has been confirmed by an FDA-approved test. The agency has cleared Ziihera under its accelerated approval pathway, and the drug’s continued availability in the U.S. will depend on data from an confirmatory trial. The companies are advancing a global confirmatory trial called HERIZON-BTC-302 designed to test Ziihera plus standard of care versus standard of care alone as a first-line option for HER2-positive BTC. Zymeworks (NASDAQ:ZYME), Jazz’s (NASDAQ:JAZZ) licensing partner for Ziihera (zanidatamab-hrii) for regions including the U.S., is set to receive a $50M milestone payment as part of the approval. The Middletown, Delaware-based biotech remains eligible to receive up to $500M in regulatory milestones linked to the drug for which regulatory reviews are currently ongoing in China and Europe. Ziihera comes with a boxed warning to indicate its potential to cause fetal toxicity during pregnancy.","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":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.30.0","shortVersion":"4.30.0","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2485460066"}