Pfizer, Genmab Get Full FDA Approval for Cervical-Cancer Drug

Dow Jones04-30

By Ben Glickman

Pfizer and Genmab on Monday said they had received full approval from U.S. regulators for their treatment for certain forms of cervical cancer.

The companies' drug Tivdak had previously been granted accelerated approval by the U.S. Food and Drug Administration, which allows quicker approval for drugs addressing a serious unmet need. The FDA's full approval covers Tivdak in the treatment of recurrent or metastatic cervical cancer.

Danish biotechnology company Genmab and Pfizer-owned Seagen codeveloped Tivdak under a cost- and profit-sharing agreement.

Tivdak has had accelerated approval from the FDA for cervical-cancer treatment since 2021.

Genmab and Pfizer said Monday that the antibody-drug conjugate had been approved to treat patients who have disease progression on or after chemotherapy, meaning it is a second-line treatment.

The approval was based on results from a Phase 3 trial of Tivdak, which met its primary endpoint of overall survival as well as its secondary endpoints, the companies said.

Write to Ben Glickman at ben.glickman@wsj.com

(END) Dow Jones Newswires

April 29, 2024 18:53 ET (22:53 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2431875874?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2024-04-30 06:53","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2431875874","market":"nz","top_or_hot":-1,"title":"Pfizer, Genmab Get Full FDA Approval for Cervical-Cancer Drug","media":"Dow Jones","content":"<font class=\"NormalMinus1\" face=\"Arial\">\n<pre>\n \n</pre>\n<p>\n  By Ben Glickman \n</p>\n<pre>\n \n</pre>\n<p>\n  Pfizer and Genmab on Monday said they had received full approval from U.S. regulators for their treatment for certain forms of cervical cancer. \n</p>\n<p>\n  The companies' drug Tivdak had previously been granted accelerated approval by the U.S. Food and Drug Administration, which allows quicker approval for drugs addressing a serious unmet need. The FDA's full approval covers Tivdak in the treatment of recurrent or metastatic cervical cancer. \n</p>\n<p>\n  Danish biotechnology company Genmab and Pfizer-owned <a href=\"https://laohu8.com/S/SGEN\">Seagen</a> codeveloped Tivdak under a cost- and profit-sharing agreement. \n</p>\n<p>\n  Tivdak has had accelerated approval from the FDA for cervical-cancer treatment since 2021. \n</p>\n<p>\n  Genmab and Pfizer said Monday that the antibody-drug conjugate had been approved to treat patients who have disease progression on or after chemotherapy, meaning it is a second-line treatment. \n</p>\n<p>\n  The approval was based on results from a Phase 3 trial of Tivdak, which met its primary endpoint of overall survival as well as its secondary endpoints, the companies said. \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Ben Glickman at ben.glickman@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  April 29, 2024 18:53 ET (22:53 GMT)\n</p>\n<p>\n  Copyright (c) 2024 Dow Jones &amp; Company, Inc.\n</p>\n</font>","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>Pfizer, Genmab Get Full FDA Approval for Cervical-Cancer Drug</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\">\nPfizer, Genmab Get Full FDA Approval for Cervical-Cancer Drug\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-04-30 06:53 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://dowjonesnews.com/newdjn/logon.aspx?AL=N><strong>Dow Jones</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>By Ben Glickman \n\n\n \n\n\n  Pfizer and Genmab on Monday said they had received full approval from U.S. regulators for their treatment for certain forms of cervical cancer. \n\n\n  The companies' drug Tivdak...</p>\n\n<a href=\"https://dowjonesnews.com/newdjn/logon.aspx?AL=N\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4581","symbol_name":"高盛持仓","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2431875874","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2431875874","pubTimestamp":1714431180,"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"Pfizer and Genmab on Monday said they had received full approval from U.S. regulators for their treatment for certain forms of cervical cancer.The companies' drug Tivdak had previously been granted accelerated approval by the U.S. Food and Drug Administration, which allows quicker approval for drugs addressing a serious unmet need. The FDA's full approval covers Tivdak in the treatment of recurrent or metastatic cervical cancer.Danish biotechnology company Genmab and Pfizer-owned Seagen codeveloped Tivdak under a cost- and profit-sharing agreement.Tivdak has had accelerated approval from the FDA for cervical-cancer treatment since 2021.Genmab and Pfizer said Monday that the antibody-drug conjugate had been approved to treat patients who have disease progression on or after chemotherapy, meaning it is a second-line treatment.The approval was based on results from a Phase 3 trial of Tivdak, which met its primary endpoint of overall survival as well as its secondary endpoints, the compani","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4581":"高盛持仓","SG9999001176.USD":"United Global Healthcare Acc USD","IE00BLSP4239.USD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis USD Plus","IE00BLSP4452.SGD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis SGD-H Plus","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","SG9999003800.SGD":"Nikko AM Global Dividend Equity Acc SGD-H","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","BK4592":"伊斯兰概念","LU0170899867.USD":"EASTSPRING INVESTMENTS WORLD VALUE EQUITY  \"A\" (USD) ACC","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","LU0456855351.SGD":"JPMorgan Funds - Global Equity A (acc) SGD","GMAB":"Genmab A/S","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","BK4585":"ETF&股票定投概念","BK4534":"瑞士信贷持仓","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","LU0122379950.USD":"贝莱德世界健康科学A2","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","BK4139":"生物科技","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","BK4533":"AQR资本管理(全球第二大对冲基金)","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","BK4007":"制药","SG9999011175.SGD":"Nikko AM Global Dividend Equity Dis SGD-H","IE00BBT3K403.USD":"LEGG MASON CLEARBRIDGE TACTICAL DIVIDEND INCOME \"A(USD) ACC","LU0234572021.USD":"高盛美国核心股票组合Acc","SG9999002232.USD":"Allianz Global High Payout USD","SG9999002224.SGD":"Allianz Global High Payout SGD","LU0058720904.USD":"联博国际健康护理基金A","BK4588":"碎股","BK4550":"红杉资本持仓","BK4568":"美国抗疫概念","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","SGXZ57979304.SGD":"United Global Healthcare A Acc SGD-H","LU1066053197.SGD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM3\" (SGDHDG) INC","PFE":"辉瑞","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC"},"translate_title":"辉瑞和Genmab获得FDA批准用于宫颈癌药物","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PFE":1,"GMAB":0.9},"content_text":"By Ben Glickman \n\n\n \n\n\n  Pfizer and Genmab on Monday said they had received full approval from U.S. regulators for their treatment for certain forms of cervical cancer. \n\n\n  The companies' drug Tivdak had previously been granted accelerated approval by the U.S. Food and Drug Administration, which allows quicker approval for drugs addressing a serious unmet need. The FDA's full approval covers Tivdak in the treatment of recurrent or metastatic cervical cancer. \n\n\n  Danish biotechnology company Genmab and Pfizer-owned Seagen codeveloped Tivdak under a cost- and profit-sharing agreement. \n\n\n  Tivdak has had accelerated approval from the FDA for cervical-cancer treatment since 2021. \n\n\n  Genmab and Pfizer said Monday that the antibody-drug conjugate had been approved to treat patients who have disease progression on or after chemotherapy, meaning it is a second-line treatment. \n\n\n  The approval was based on results from a Phase 3 trial of Tivdak, which met its primary endpoint of overall survival as well as its secondary endpoints, the companies said. \n\n\n \n\n\n  Write to Ben Glickman at ben.glickman@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  April 29, 2024 18:53 ET (22:53 GMT)\n\n\n  Copyright (c) 2024 Dow Jones & Company, Inc.","kind":null,"is_publish_news":null,"is_publish_highlight":null,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"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":"4.22.4","shortVersion":"4.22.4","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/2431875874"}