EMA Committee Endorses AbbVie's Elahere in Ovarian Cancer

Zacks09-23

AbbVie ABBV announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approving the regulatory filing seeking approval for its ovarian cancer drug Elahere (...

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The study achieved its primary endpoint — treatment with Elaherereduced the risk of tumor progression or death by 35% compared with chemotherapy.The CHMP’s recommendation will now be reviewed by the European Commission  and a final decision is expected later this year. Though the EC generally follows the CHMP recommendation, it is not bound to do so","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"SG9999011175.SGD":"Nikko AM Global Dividend Equity Dis SGD-H","IE00BJT1NW94.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","LU0321505868.SGD":"Schroder ISF Global Dividend Maximiser A Dis SGD","IE000M9KFDE8.USD":"NEUBERGER BERMAN US LARGE CAP VALUE \"A\" (USD) ACC","LU0234572021.USD":"高盛美国核心股票组合Acc","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","MRK":"默沙东","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","LU0265550946.USD":"BGF SYSTEMATIC GLOBAL ENHANCED EQUITY YIELD \"A5\" (USD) INC","LU0661504455.SGD":"Blackrock Global Equity Income A5 SGD-H","PFE":"辉瑞","LU0795875086.SGD":"JPMorgan Investment Funds - Global Income A (div) SGD","BK4007":"制药","LU1430594728.SGD":"Eastspring Investments - Global Low Volatility Equity AS SGD","SG9999003800.SGD":"Nikko AM Global Dividend Equity Acc SGD-H","ABBV":"艾伯维公司","LU0949170772.SGD":"Blackrock Global Equity Income A6 SGD-H","LU1894683348.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) INC","LU0211331839.USD":"FRANKLIN MUTUAL GLB DISCOVERY \"A\" (USD) ACC","LU0861579265.USD":"联博低波幅策略股票基金A","LU0198837287.USD":"UBS (LUX) EQUITY SICAV - USA GROWTH \"P\" (USD) ACC","EC":"哥伦比亚国家石油","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","LU0820561818.USD":"安联收益及增长平衡基金Cl AM DIS","LU1116320737.USD":"BGF SYSTEMATIC GLOBAL ENHANCED EQUITY YIELD \"A6\" (USD) INC","AZN":"阿斯利康","LU0738911758.USD":"Blackrock Global Equity Income A6 USD","LU1585245621.USD":"EASTSPRING INV GLOBAL LOW VOLATILITY EQUITY FUND \"A\" (USD) ACC B","SG9999001176.USD":"United Global Healthcare Acc USD","LU1829250122.USD":"高盛欧洲核心股票组合Acc","LU0029864427.USD":"TEMPLETON GLOBAL \"A\" (USD) INC","IE00B4R5TH58.HKD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (HKD) ACC","BK4516":"特朗普概念","LU0943347566.SGD":"安联收益及增长平衡基金AM H2-SGD","LU1003077747.HKD":"BGF GLOBAL EQUITY INCOME \"A6\" (HKDHDG) INC","ADC":"艾格里房产","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","LU0417517546.SGD":"Allianz US Equity Cl AT Acc SGD","LU0912757837.SGD":"JPMorgan Investment Funds - Global Income A (mth) SGD-H","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","LU0456855351.SGD":"JPMorgan Funds - Global Equity A (acc) SGD","LU1037948897.HKD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (HKD) INC","LU1941712264.USD":"ALLIANZ PET AND ANIMAL WELLBEING \"A\" (USD) INC","BK4588":"碎股","LU0985481810.HKD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (HKD) INC M","LU0545039389.USD":"BGF GLOBAL EQUITY INCOME \"A2\" ACC","BK4139":"生物科技","CHMP":"冠军工业","BK4080":"零售业房地产投资信托"},"translate_title":"EMA委员会认可艾伯维的Elahere治疗卵巢癌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ADC":1,"MRK":1,"EC":1,"CHMP":1,"ABBV":1,"AZN":1,"PFE":0.7},"content_text":"AbbVie ABBV announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approving the regulatory filing seeking approval for its ovarian cancer drug Elahere (mirvetuximab soravtansine) in the EU.\nAbbVie’s filing seeks marketing authorization for Elahere to treat adult patients with FRα-positive, platinum-resistant and high-grade serious epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior treatments.\nThis recommendation is based on data from data from the phase III MIRASOL study, which evaluated ABBV’s drug against the investor’s choice of single-agent chemotherapy in the given patient population. The study achieved its primary endpoint — treatment with Elaherereduced the risk of tumor progression or death by 35% compared with chemotherapy.\nThe CHMP’s recommendation will now be reviewed by the European Commission (EC) and a final decision is expected later this year. Though the EC generally follows the CHMP recommendation, it is not bound to do so. If approved, this will be the first regulatory approval for Elahere in the EU.\nABBV Stock Performance\nYear to date, AbbVie’s shares have moved up 24.9% compared with the industry’s 23.5% rise.\nImage Source: Zacks Investment Research\nRecent Developments Related to ABBV’s Elahere\nElahere was recently granted full approval by the FDA for a similar indication, also supported by data from the MIRASOL study. The drug was initially approved for this indication under the accelerated pathway in 2022.\nA first-in-class antibody-drug conjugate (ADC), Elahere, was added to AbbVie’s portfolio earlier this year in February following the acquisition of ImmunoGen for $10.1 billion. The drug is also being evaluated in multiple studies, both as monotherapy and in combination with other drugs, for ovarian cancer, which is likely to expand its use in earlier lines of therapy and additional patient populations.\nIn June, AbbVie reported positive results from the phase II PICCOLO study, which evaluated Elahere in heavily pre-treated patients with FRα-positive platinum-sensitive ovarian cancer (PSOC). The study achieved its primary endpoint — patients treated with Elahere achieved an objective response rate (ORR) of 51.9%.\nApart from Elahere, the ImmunoGen acquisition also added some other promising ADC candidates in AbbVie’s pipeline, like pivekimab sunirine (in phase II studies for blastic plasmacytoid dendritic cell neoplasm and acute myeloid leukemia) and IMGN-151 (in phase I studies for ovarian and endometrial cancers).\nADCs are next-generation treatments that target cancer cells by delivering highly potent cancer-killing agents through a targeted antibody.\nStiff Competition in the ADC Space\nThrough the ImmunoGen acquisition, ABBV diversified its oncology pipeline and forayed into the ADC space, which garnered interest from big pharma like AstraZeneca AZN, Merck MRK and Pfizer PFE. These companies have made multi-billion-dollar investments in this space to develop and market novel ADC drugs.\nIn May, AstraZeneca announced plans to spend $1.5 billion to build its first manufacturing facility in Singapore which will cover the full manufacturing process for its ADC portfolio. AZN has a broad portfolio of in-house ADCs, including six wholly-owned ADCs in its clinical pipeline and many more in preclinical development.\nThis focus on ADCs comes from the success achieved by AstraZeneca from its only marketed ADC drug in its portfolio, Enhertu, which has been developed in collaboration with partner Daiichi Sankyo. Since its initial launch in 2019, Enhertu has shown an impressive initial uptake. During first-half 2024, Enhertu generated $683 million in alliance revenues for AstraZeneca, up 44% from the year-ago period’s figures.\nThe AZN drug is presently approved across multiple indications, including advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer (NSCLC) and metastatic HER2-positive and HER2-low breast cancer. The fifth indication, i.e., metastatic HER2-positive solid tumors, was approved by the FDA in April.\nPfizer entered into this space when it acquired ADC drugmaker Seagen last year for $43 billion. Post this acquisition, PFE added three ADCs to its portfolio — Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin) and Tivdak (tisotumab vedotin) — all approved across solid tumors and hematologic malignancies. Per the deal, Pfizer also acquired Seagen’s proprietary ADC technology.\nTo boost its oncology portfolio, Merck signed a deal with Daiichi Sankyo last year to jointly develop and market three investigational ADC drugs for a total potential consideration of up to $22 billion. MRK’s deal with Daiichi involves three ADCs, namely patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan, which are across multiple solid tumor indications in different stages of clinical development. Per Merck, this deal holds multi-billion dollar worldwide commercial revenue potential for each company approaching the mid-2030s.\n\nAbbVie Inc. Price\n\nAbbVie Inc. price | AbbVie Inc. Quote\n\n \nABBV’s Zacks Rank\nAbbVie currently carries a Zacks Rank #3 (Hold).\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\nAstraZeneca PLC (AZN) : Free Stock Analysis Report\nPfizer Inc. (PFE) : Free Stock Analysis Report\nMerck & Co., Inc. (MRK) : Free Stock Analysis Report\nAbbVie Inc. (ABBV) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"Policy And Regulatory","news_rank":0,"symbols":[],"gpt_button":0},"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":"4.28.1","shortVersion":"4.28.1","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/2469254141"}