GILD's Trodelvy Gets Second Breakthrough Therapy Tag for Lung Cancer

Zacks12-18

Gilead Sciences GILD announced that its first-in-class Trop-2-directed antibody-drug conjugate, Trodelvy (sacituzumab govitecan-hziy), has been granted a second Breakthrough Therapy designation by the...

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The indicated population includes adult patients with extensive-stage small cell lung cancer  whose disease has progressed on or after platinum-based chemotherapy.Gilead’s Trodelvy is currently approved for second-line or later metastatic triple-negative breast cancer  patients in more than 50 countries and for certain patients with pre-treated HR+/HER2- metastatic breast cancer  in more than 40 countries, including the United States. The first Breakthrough Therapy designation was granted to Trodelvy for the TNBC indication in the United States.Benefits of the FDA’s Breakthrough Therapy Designation Grant. The FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions. This designation is granted when","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"IE00BKVL7J92.USD":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD","LU1585245621.USD":"EASTSPRING INV GLOBAL LOW VOLATILITY EQUITY FUND \"A\" (USD) ACC B","LU1571399168.USD":"ALLSPRING GLOBAL LONG/SHORT EQUITY \"IP\" (USD) ACC","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","CSTL":"Castle Biosciences, Inc.","GILD":"吉利德科学","IE00B3T34201.USD":"BNY MELLON GLOBAL EQUITY INCOME \"B\" (USD) INC","BK4583":"猴痘概念","IE00B7SZLL34.SGD":"Legg Mason ClearBridge - Value A Acc SGD-H","BK4532":"文艺复兴科技持仓","LU1839511570.USD":"WELLS FARGO GLOBAL FACTOR ENHANCED EQUITY \"I\" (USD) ACC","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","BK4585":"ETF&股票定投概念","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","BK4139":"生物科技","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","BK4566":"资本集团","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","BK4196":"保健护理服务","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","MBC":"MasterBrand, Inc.","BK4578":"CAR-T","LU0058720904.USD":"联博国际健康护理基金A","CTMX":"CytomX","IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)","BK4550":"红杉资本持仓","BK4588":"碎股","LU0234570918.USD":"高盛全球核心股票组合Acc Close","SPRO":"Spero Therapeutics Inc.","BK4568":"美国抗疫概念","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","LU1430594728.SGD":"Eastspring Investments - Global Low Volatility Equity AS SGD","LU1066053197.SGD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM3\" (SGDHDG) INC","LU2087621335.USD":"ALLSPRING GLOBAL FACTOR ENHANCED EQUITY \"A\" (USD) ACC","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","BK4086":"建筑产品","LU2468319806.SGD":"MANULIFE GF HEALTHCARE \"AA\" (SGDHDG) ACC"},"translate_title":"GILD的Trodelvy获得第二个肺癌突破性疗法标签","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SPRO":1,"MBC":1,"GILD":1,"CSTL":1,"CTMX":1},"content_text":"Gilead Sciences GILD announced that its first-in-class Trop-2-directed antibody-drug conjugate, Trodelvy (sacituzumab govitecan-hziy), has been granted a second Breakthrough Therapy designation by the FDA for a lung cancer indication. The indicated population includes adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy.\nGilead’s Trodelvy is currently approved for second-line or later metastatic triple-negative breast cancer (TNBC) patients in more than 50 countries and for certain patients with pre-treated HR+/HER2- metastatic breast cancer (MBC) in more than 40 countries, including the United States. The first Breakthrough Therapy designation was granted to Trodelvy for the TNBC indication in the United States.\nBenefits of the FDA’s Breakthrough Therapy Designation Grant\nThe FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions. This designation is granted when early clinical evidence suggests the drug may significantly improve over existing treatments on an important clinical measure. Drugs with this designation receive more intensive guidance and organizational support from senior FDA managers.\nIn the past three months, shares of Gilead have gained 10.6% against the industry’s 10.8% decline.\nImage Source: Zacks Investment Research\nThe FDA's decision is based on promising results from the global phase II TROPiCS-03 study in patients with ES-SCLC. Per the data readout, Trodelvy showed encouraging antitumor activity as a second-line treatment in both platinum-resistant and platinum-sensitive cases, with a safety profile consistent with previous studies. These findings support further research, and Gilead plans to launch a late-stage study to evaluate the drug in this patient group.\nLung cancer is the second most common cancer in the United States and the leading cause of cancer-related deaths. About 15% of lung cancer cases are SCLC, with nearly 70% of these diagnosed at an extensive stage, where the cancer has spread to both lungs or other parts of the body. Patients with ES-SCLC who do not respond to first-line treatments often face a poor prognosis with limited treatment options. This highlights a critical need for new, more effective therapies to improve survival and slow disease progression.\nPlease note that Gilead is currently evaluating Trodelvy alone or in combination with other agents, across late-stage studies, for various cancer types, comprising certain other TNBC and HR+/HER2- breast cancer groups, as well as tumors with high Trop-2 expression. These include SCLC, where the drug showed promise in the TROPiCS-03 study, and first-line metastatic non-small cell lung cancer, demonstrated in the EVOKE-02 study. Additionally, Trodelvy is being studied for potential use in head and neck cancer and gynecological cancers.\nGILD Signs Collaboration Agreement With Terray Therapeutics\nIn a separate press release, Gilead announced that it has entered into a strategic collaboration with Terray Therapeutics, an AI-powered biotech, to discover and develop novel, small molecule therapies across multiple targets.\nPer the terms of the agreement, Terray will use its proprietary tNova platform to discover and develop small molecule compounds for targets selected by Gilead. If Gilead exercises its exclusive option to license the compounds, the company will assume responsibility for further development and commercialization.\nIn consideration of the above arrangement, Gilead is liable to pay Terray an undisclosed upfront amount. Terray is also eligible to receive milestone payments for preclinical, clinical and sales achievements from Gilead, along with tiered royalties on net sales of GILD’s products resulting from the collaboration.\nGilead includes acquired IPR&D expenses in its GAAP and non-GAAP financial measures. This deal is expected to reduce Gilead’s 2024 GAAP and non-GAAP EPS by about 1 cent.\n\nGilead Sciences, Inc. Price and Consensus\n\nGilead Sciences, Inc. price-consensus-chart | Gilead Sciences, Inc. Quote\n\nGILD’s Zacks Rank & Other Stocks to Consider\nGilead currently carries a Zacks Rank #2 (Buy).\nSome other top-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and Spero Therapeutics SPRO, each sporting 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, 2024 estimates for Castle Biosciences have improved from a loss of 59 cents per share to earnings of 34 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.15 to $1.84. In the past three months, shares of Castle Biosciences have lost 7.8%.\nCSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.\nIn the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 5 cents. Estimates for 2025 loss per share have narrowed from 56 cents to 35 cents during the same timeframe. In the past three months, CTMX stock has lost 3.4%.\nCytomX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.\nIn the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Estimates for 2025 loss per share have narrowed from $1.54 to 79 cents during the same timeframe. In the past three months, Spero’s shares have lost 23.6%.\nSPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.\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\nGilead Sciences, Inc. (GILD) : Free Stock Analysis Report\nCytomX Therapeutics, Inc. (CTMX) : 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":"2","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":"4.29.3","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/2492135482"}