FDA Accepts Roche's Columvi sBLA for Expanded Use in Lymphoma

Zacks12-05

Roche RHHBY announced that the FDA has accepted its supplemental biologics license application (sBLA) seeking expanded use of Columvi (glofitamab) for second-line relapsed or refractory (R/R) diffuse ...

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The eligible population includes DLBCL patients who have received at least one prior line of treatment  and are not candidates for autologous stem cell transplant. A final decision from the regulatory body is expected on July 20, 2025.The STARGLO study is designed as a confirmatory study to convert the accelerated approval of Columvi in the United States and conditional marketing authorization in the EU to full approvals for third-line R/R DLBCL. Roche is also currently evaluating Columvi in combination with Polivy , MabThera/Rituxan, cyclophosphamide, doxorubicin and prednisone in the phaseIII SKYGLO study to treat previou","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","IE00BBT3K403.USD":"LEGG MASON CLEARBRIDGE TACTICAL DIVIDEND INCOME \"A(USD) ACC","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","LU0321505868.SGD":"Schroder ISF Global Dividend Maximiser A Dis SGD","LU0321505439.SGD":"Schroder ISF Global Dividend Maximiser A Acc SGD","LU0234572021.USD":"高盛美国核心股票组合Acc","LU0985481810.HKD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (HKD) INC M","LU0306806265.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" ACC","SG9999002224.SGD":"Allianz Global High Payout SGD","LU0058720904.USD":"联博国际健康护理基金A","BK4568":"美国抗疫概念","LU0053671581.USD":"摩根大通美国小盘成长股 A(dist)","LU1430594728.SGD":"Eastspring Investments - Global Low Volatility Equity AS SGD","LU2087621335.USD":"ALLSPRING GLOBAL FACTOR ENHANCED EQUITY \"A\" (USD) ACC","PFE":"辉瑞","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","03165":"华夏欧优股对冲","RHHBY":"罗氏控股","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","GILD":"吉利德科学","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","LU2468319806.SGD":"MANULIFE GF HEALTHCARE \"AA\" (SGDHDG) ACC","LU0225284248.USD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" ACC","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","BK4533":"AQR资本管理(全球第二大对冲基金)","SOC":"Sable Offshore Corp.","HALO":"奥洛兹美医疗","LU1585245621.USD":"EASTSPRING INV GLOBAL LOW VOLATILITY EQUITY FUND \"A\" (USD) ACC B","LU1894683348.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) INC","SG9999001176.USD":"United Global Healthcare Acc USD","BK4583":"猴痘概念","IE00BLSP4452.SGD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis SGD-H Plus","IE00BLSP4239.USD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis USD Plus","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","IE00B7SZLL34.SGD":"Legg Mason ClearBridge - Value A Acc SGD-H","SGXZ57979304.SGD":"United Global Healthcare A Acc SGD-H","IE00B3T34201.USD":"BNY MELLON GLOBAL EQUITY INCOME \"B\" (USD) INC","BK4007":"制药","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","BK4599":"减肥药","BK4592":"伊斯兰概念","BK4532":"文艺复兴科技持仓","LU1883839398.USD":"AMUNDI FUNDS INCOME OPPORTUNITIES \"A2\" (USD) ACC","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","BK4585":"ETF&股票定投概念","BK4534":"瑞士信贷持仓","LU1894683264.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) ACC","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","BK4566":"资本集团"},"translate_title":"FDA接受罗氏Columvi sBLA扩大用于淋巴瘤","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SOC":1,"RHHBY":1,"GILD":1,"HALO":1,"PFE":0.9,"03165":0.6},"content_text":"Roche RHHBY announced that the FDA has accepted its supplemental biologics license application (sBLA) seeking expanded use of Columvi (glofitamab) for second-line relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) for review. The eligible population includes DLBCL patients who have received at least one prior line of treatment (second-line setting) and are not candidates for autologous stem cell transplant. A final decision from the regulatory body is expected on July 20, 2025.\nPlease note that Columvi is already approved in the United States under the FDA’s accelerated approval pathway as a monotherapy for treating people with R/R DLBCL after two or more lines of systemic therapy (third-line setting). The drug has also received conditional marketing authorization in the EU and is currently approved in more than 50 countries globally for the same indication.\nColumvi is a first-of-its-kind CD20xCD3 T-cell-engaging bispecific antibody with a novel mechanism of action. Per RHHBY, the drug has been used to treat over 3,000 patients in clinical studies and more than 2,600 in real-world practice.\nIn the past three months, shares of Roche have lost 11.4% compared with the industry’s 11.8% decline.\nImage Source: Zacks Investment Research\nMore on the FDA Acceptance of RHHBY’s Columvi sBLA\nRoche’s sBLA for the Columvi, in combination with gemcitabine and oxaliplatin (GemOx), to treat second-line R/R DLBCL is supported by findings from the phase III STARGLO study. The combination therapy showed a statistically significant and clinically meaningful improvement in overall survival compared to MabThera/Rituxan (rituximab) with GemOx, making it the first CD20xCD3 bispecific antibody to show a survival benefit in DLBCL in a randomized phase III study. The Columvi/GemOx combo was well-tolerated and demonstrated a safety profile consistent with the individual medicines.\nThe current standard of care (SOC) for second-line R/R DLBCL is high-dose chemotherapy followed by stem-cell transplant. However, many patients are ineligible for this approach due to factors like age or underlying health conditions. Although newer therapies are emerging, significant barriers persist, highlighting the need for alternative treatment options to enhance survival outcomes.\nRoche believes in the potential of the Columvi combo therapy to replace the current SOC given the significant survival benefit observed in the STARGLO study. The company has also submitted study data to other regulatory bodies around the world for approval consideration, including in the EU.\nThe STARGLO study is designed as a confirmatory study to convert the accelerated approval of Columvi in the United States and conditional marketing authorization in the EU to full approvals for third-line R/R DLBCL. Roche is also currently evaluating Columvi in combination with Polivy (elotuzumab vedotin), MabThera/Rituxan, cyclophosphamide, doxorubicin and prednisone in the phase III SKYGLO study to treat previously untreated DLBCL patients (first-line setting).\nDLBCL is the most common form of non-Hodgkin’s lymphoma (NHL) and is aggressive (fast-growing) in nature. DLBCL accounts for approximately one-third of all NHL cases. An estimated number of 160,000 people are diagnosed with DLBCL every year, globally. NHL is a type of B-cell malignancy that begins in damaged B cells and affects the lymphatic system, which is part of the immune system.\n\nRoche Holding AG Price and Consensus\n\nRoche Holding AG price-consensus-chart | Roche Holding AG Quote\n\nRHHBY’s Zacks Rank & Stocks to Consider\nRoche currently carries a Zacks Rank #3 (Hold).\nSome better-ranked pharma stocks are Halozyme Therapeutics HALO, Pfizer PFE and Gilead Sciences GILD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.\nOver the past 60 days, Halozyme Therapeutics’ earnings estimates have risen from $3.95 to $4.05 per share for 2024, while that for 2025 has increased from $4.73 to $4.80. HALO shares have lost 17.9% in the past three months.\nHalozyme Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 14.86%.\nIn the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.84 to $2.91. PFE shares have lost 11.7% in the past three months.\nPfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.\nIn the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.79 to $4.32 per share for 2024, while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 16.3% in the past three months.\nGilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.\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\nRoche Holding AG (RHHBY) : Free Stock Analysis Report\nPfizer Inc. (PFE) : Free Stock Analysis Report\nGilead Sciences, Inc. (GILD) : Free Stock Analysis Report\nHalozyme Therapeutics, Inc. (HALO) : 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":"","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":"4.29.3","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/2489245032"}