Merck’s Keytruda with Pfizer’s Padcev approved in EU for first-line bladder cancer

seekingalpha09-03

Merck (NYSE:MRK) on Tuesday announced that the European Commission approved its blockbuster therapy Keytruda as a first-line option for a type of bladder cancer in combination with Padcev developed by...

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Accordingly, the anti-PD-1 therapy will be indicated in the region for adults with unresectable or metastatic urothelial carcinoma with Padcev, an antibody-drug conjugate that Pfizer (PFE) added with its Seagen acquisition in 2023.  The decision will apply to all 27 European Union member states, plus Iceland, Liechtenstein, Norway, and Northern Ireland. It also marks the third indication that Keytruda was approved in the EU for bladder cancer, and the 28th indication overall. The approval comes after an expert panel of the EU drug regulator European Medicines Agency (EMA) endorsed the treatment in July based on data from the companies’ Phase 3 KEYNOTE-A39 trial.","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":"4.29.1","shortVersion":"4.29.1","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/2464709478"}