ODAC to Discuss Exelixis' Application for Cabometyx Label Expansion

Zacks11-28

Exelixis, Inc. EXEL announced that its supplemental new drug application (sNDA) for cabozantinib will be discussed at an Oncologic Drugs Advisory Committee (“ODAC”) meeting in March 2025. The sNDA is ...

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EXEL announced that its supplemental new drug application (sNDA) for cabozantinib will be discussed at an Oncologic Drugs Advisory Committee (“ODAC”) meeting in March 2025.\nThe sNDA is ...</p>\n\n<a href=\"https://finance.yahoo.com/news/odac-discuss-exelixis-application-cabometyx-162900490.html\">Source Link</a>\n\n</div>\n","source":"yahoofinance","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>ODAC to Discuss Exelixis' Application for Cabometyx Label Expansion</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\">\nODAC to Discuss Exelixis' Application for Cabometyx Label Expansion\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-28 00:29 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/odac-discuss-exelixis-application-cabometyx-162900490.html><strong>Zacks</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Exelixis, Inc. EXEL announced that its supplemental new drug application (sNDA) for cabozantinib will be discussed at an Oncologic Drugs Advisory Committee (“ODAC”) meeting in March 2025.\nThe sNDA is ...</p>\n\n<a href=\"https://finance.yahoo.com/news/odac-discuss-exelixis-application-cabometyx-162900490.html\">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":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://finance.yahoo.com/news/odac-discuss-exelixis-application-cabometyx-162900490.html","article_id":"2486803311","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/cYhdSHZ3kDYVQNhcMTsM_w--~B/aD0zOTM7dz02MjA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/4a0e141116a5c1fff5e57140486a1890"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2486803311","pubTimestamp":1732724940,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Exelixis, Inc. EXEL announced that its supplemental new drug application  for cabozantinib will be discussed at an Oncologic Drugs Advisory Committee  meeting in March 2025.The sNDA is seeking approval for the drug to treat adults with previously treated advanced pancreatic neuroendocrine tumors  and advanced extra-pancreatic NET .Exelixis’ shares have surged 48.9% year to date against the industry’s decline of 7.8%.The company was notified of the update on the ODAC meeting by the FDA. ODACs mostly review and evaluate data regarding the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and make recommendations to the Commissioner of Food and Drugs.Per EXEL, the planned ODAC meeting is not related to the currently approved indications for Cabometyx in the United States.In August 2024, the FDA granted cabozantinib orphan drug designation for the treatment of pNET and assigned a target action date of April 3, 2025.EXEL’s Effort","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","EXEL":"伊克力西斯","CSTL":"Castle Biosciences, Inc.","LU1989772840.SGD":"CPR Invest - Climate Action A2 Acc SGD-H","LU1989771016.USD":"东方汇理环球老龄化投资基金 A2 Acc","IE00BN8TJ469.HKD":"FTGF CLEARBRIDGE TACTICAL DIVIDEND INCOME \"A\" (HKD) INC","LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","LU1037948897.HKD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (HKD) INC","BK4195":"互助储蓄与抵押信贷金融服务","LU0238689110.USD":"贝莱德环球动力股票基金","LU2023250504.SGD":"Allianz Thematica Cl AMg DIS H2-SGD","IE00BBT3K403.USD":"LEGG MASON CLEARBRIDGE TACTICAL DIVIDEND INCOME \"A(USD) ACC","HCC":"Warrior Met Coal LLC","LU2023250843.SGD":"Allianz Thematica Cl AT Acc H2-SGD","SPRO":"Spero Therapeutics Inc.","BK4550":"红杉资本持仓","LU1037948541.HKD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"A\" (HKD) ACC","LU0058720904.USD":"联博国际健康护理基金A","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","LU0234572021.USD":"高盛美国核心股票组合Acc","BK4006":"钢铁","LU0965509010.AUD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (AUDHDG) INC","LU1061106388.HKD":"BGF WORLD HEALTHSCIENCE \"A2\" (HKDHDG) ACC","SG9999014567.USD":"UOB UNITED INCOME FOCUS TRUST FUND (USD) ACC","LU2361044949.HKD":"WELLINGTON US QUALITY GROWTH \"A\" (HKD) ACC","LU1934455863.HKD":"AB SICAV I LOW VOLATILITY TOTAL RETURN EQUITY PORT \"A\" (HKD) ACC","LU2361044865.SGD":"WELLINGTON US QUALITY GROWTH \"A\" (SGDHDG) ACC","LU0861579265.USD":"联博低波幅策略股票基金A","LU2361045086.USD":"WELLINGTON US QUALITY GROWTH \"A\" (USD) ACC","LU0122379950.USD":"贝莱德世界健康科学A2","LU1291159041.SGD":"CPR Invest - Global Silver Age A2 Acc SGD-H","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","MRK":"默沙东","LU1116320737.USD":"BGF SYSTEMATIC GLOBAL ENHANCED EQUITY YIELD \"A6\" (USD) INC","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","SG9999001440.SGD":"United Global Dividend Equity Fund A SGD Dist","LU1066051225.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AC\" (USD) ACC","SG9999014542.SGD":"United Income Focus Trust Acc SGD","LU0203345920.USD":"SCHRODER ISF QEP GLB ACT. 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EXEL announced that its supplemental new drug application (sNDA) for cabozantinib will be discussed at an Oncologic Drugs Advisory Committee (“ODAC”) meeting in March 2025.\nThe sNDA is seeking approval for the drug to treat adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET).\nExelixis’ shares have surged 48.9% year to date against the industry’s decline of 7.8%.\nImage Source: Zacks Investment Research\nDetails of EXEL’s sNDA for Cabometyx\nThe company was notified of the update on the ODAC meeting by the FDA.  ODACs mostly review and evaluate data regarding the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and make recommendations to the Commissioner of Food and Drugs.\nPer EXEL, the planned ODAC meeting is not related to the currently approved indications for Cabometyx in the United States.\nCabozantinib is approved under the brand name Cabometyx as monotherapy for the treatment of patients with advanced renal cell carcinoma (RCC) and in combination with Opdivo (nivolumab) as a first-line treatment for patients with advanced RCC.\nCabometyx is approved for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; and for adult and pediatric patients aged 12 years and above with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible.\nIn August 2024, the FDA granted cabozantinib orphan drug designation for the treatment of pNET and assigned a target action date of April 3, 2025.\nThe sNDA is based on the final results of the phase III CABINET pivotal trial, conducted by the National Cancer Institute's National Clinical Trials Network.\nThe trial evaluated cabozantinib compared with placebo in advanced pNET and advanced epNET.\nIn August 2023, the Alliance for Clinical Trials in Oncology independent Data and Safety Monitoring Board unanimously recommended that enrollment in the CABINET trial be stopped and randomized patients be unblinded to therapy with the allowance for crossover from placebo to cabozantinib due to the substantial improvement in progression-free survival (PFS) observed at this interim analysis.\nFinal results from the enrolled patient population confirmed statistically significant and clinically meaningful improvements with cabozantinib versus placebo in the primary endpoint of PFS by blinded independent central review.\nEXEL’s Efforts to Expand Cabometyx Label, Diversify Portfolio\nExelixis also intends to submit an sNDA with the FDA later this year for cabozantinib, in combination with Tecentriq (atezolizumab), for metastatic castration-resistant prostate cancer.\nExelixis generated $1.3 billion of product revenues in the first nine months of 2024, primarily from Cabometyx sales.\nA potential label expansion should boost sales further.\nThe pipeline progress has also been impressive as Exelixis looks to expand its oncology portfolio beyond Cabometyx.\nAnother promising candidate in Exelixis’ pipeline is zanzalintinib, a next-generation oral TKI. Enrollment has been completed in the late-stage STELLAR-303 study evaluating zanzalintinib, in combination with Tecentriq, compared with regorafenib in patients with metastatic refractory colorectal cancer that is not microsatellite instability-high or mismatch repair-deficient. Preliminary results from the study are expected in 2025.\nExelixis recently collaborated with pharma giant Merck MRK to evaluate zanzalintinib in combination with Merck’s blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) in a late-stage study for treating patients with head and neck squamous cell carcinoma (HNSCC).\nBoth the companies will also evaluate zanzalintinib with Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor Welireg (belzutifan) in a phase I/II study and two phase III studies for the treatment of patients with RCC.\nPer the terms of the agreement, Merck will supply Keytruda for the ongoing, Exelixis-sponsored phase III STELLAR-305 study in previously untreated PD-L1 positive recurrent or metastatic HNSCC.\nThe successful development of additional drugs should broaden its portfolio and reduce its dependence on its lead drug, Cabometyx.\nZacks Rank & Other Key Picks\nEXEL currently carries a Zacks Rank #2 (Buy).\nSome other top-ranked stocks in the biotech sector are Spero Therapeutics SPRO and Castle Biosciences, Inc. CSTL, both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.\nIn the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.13. Estimates for 2025 loss per share have narrowed from $1.54 to 54 cents.\nSpero Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average surprise of 94.42%.\nIn the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time frame. Year to date, shares of CSTL have surged 41.4%.\nCSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%. \nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nMerck & Co., Inc. (MRK) : Free Stock Analysis Report\nExelixis, Inc. (EXEL) : Free Stock Analysis Report\nSpero Therapeutics, Inc. (SPRO) : Free Stock Analysis Report\nCastle Biosciences, Inc. (CSTL) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","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":"corporation","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":"4.29.3","shortVersion":"4.29.3","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/2486803311"}