Pfizer Wins FDA Nod to Expand Label for Braftovi + Mektovi in Lung Cancer

seekingalpha2023-10-13

Pfizer announced Thursday that the U.S. FDA approved its marketing application to expand the label for its kinase inhibitors Braftovi (encorafenib) + Mektovi (binimetinib) for a group of lung cancer ...

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CEO Albert Bourla Presents at Cantor Fitzgerald Annual Global Health Conference  Pfizer: Protracted Selloff Make","collect":0,"end_time":0,"defaultTopTitle":"seekingalpha.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"PFE":"辉瑞"},"translate_title":"辉瑞赢得FDA批准扩大Braftovi+Mektovi在肺癌中的标签","themeId":"c5bbfdf5f7964880af97c1d6f417052c","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PFE":1},"content_text":"Pfizer announced Thursday that the U.S. FDA approved its marketing application to expand the label for its kinase inhibitors Braftovi (encorafenib) + Mektovi (binimetinib) for a group of lung cancer patients with a particular genetic mutation.Accordingly, Braftovi + Mektovi will be allowed as a new personalized treatment for adults whose metastatic non-small cell lung cancer (NSCLC) indicates a BRAF V600E mutation, as confirmed by an FDA-approved test.The FDA first approved the therapeutic combo in 2018 for certain patients with melanoma harboring the BRAF V600E or V600K mutation.The latest approval is based on data from an ongoing Phase 2 trial called PHAROS, which met both efficacy outcome measures of objective response rate and duration of response in patients with BRAF V600E-mutant metastatic NSCLC.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":1,"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/2375958918"}