{"id":62308,"date":"2026-08-07T09:48:27","date_gmt":"2026-08-07T09:48:27","guid":{"rendered":"https:\/\/www.europesays.com\/news\/62308\/"},"modified":"2026-08-07T09:48:27","modified_gmt":"2026-08-07T09:48:27","slug":"fda-clears-replimune-melanoma-drug-rp1-for-continued-testing","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/news\/62308\/","title":{"rendered":"FDA clears Replimune melanoma drug RP1 for continued testing"},"content":{"rendered":"<p class=\"author-bio\">Elaine\u2019s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes <a href=\"https:\/\/www.statnews.com\/signup\/readout\/\" rel=\"nofollow noopener\" target=\"_blank\">The Readout newsletter<\/a>, and co-hosts STAT\u2019s weekly biotech podcast, <a href=\"https:\/\/www.statnews.com\/category\/readout-loud\/\" rel=\"nofollow noopener\" target=\"_blank\">The Readout Loud<\/a>. You can reach Elaine on Signal at elaineywchen.70.<\/p>\n<p class=\"wp-block-paragraph\">The Food and Drug Administration has cleared Replimune\u2019s treatment for advanced melanoma, dealing the biotech a major win after a tumultuous saga of trying to seek approval for the controversial treatment.<\/p>\n<p class=\"wp-block-paragraph\">The FDA\u2019s decision to grant accelerated approval to the drug, which is called RP1 and will be marketed as Tudriqev, came after its <a href=\"https:\/\/www.statnews.com\/2026\/07\/30\/replimune-melanoma-drug-rp1-fda-expert-meeting-live-blog\/\" rel=\"nofollow noopener\" target=\"_blank\">advisers last week voted in support of the treatment<\/a>. Even though FDA staff expressed concerns about the design and conduct of Replimune\u2019s key trial, advisers ultimately believed there was a large enough signal of efficacy and that patients are in urgent need of new treatments.<\/p>\n<p class=\"wp-block-paragraph\">The list price of Tudriqev will be $450,000 per course of therapy before customary rebates and discounts, Replimune said.<\/p>\n<p class=\"restricted-text\">STAT+ Exclusive Story<\/p>\n<p class=\"restricted-login\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta\" rel=\"nofollow noopener\" target=\"_blank\">Log in<\/a><\/p>\n<p>\t\t\t<img decoding=\"async\" class=\"restricted-content-breaker-bg\" src=\"https:\/\/www.europesays.com\/news\/wp-content\/uploads\/2026\/03\/stat-plus-breaker-bg.png\" alt=\"STAT+\"\/><\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" rel=\"nofollow noopener\" target=\"_blank\"><br \/>\n\t\t\t\t\t\t<img decoding=\"async\" class=\"stat-plus-logo\" src=\"https:\/\/www.statnews.com\/wp-content\/themes\/stat\/images\/stat-plus-logo-white.svg\" alt=\"STAT+\"\/><br \/>\n\t\t\t\t\t<\/a><\/p>\n<p>\t\t\t\tThis article is exclusive to STAT+ subscribers<br \/>\n\t\t\t\tUnlock this article \u2014 plus daily coverage and analysis of the biotech sector \u2014 by subscribing to STAT+.<\/p>\n<p class=\"restricted-content-breaker-wrapper-cta mobile\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta mobile\" rel=\"nofollow noopener\" target=\"_blank\">Log in<\/a><\/p>\n<p>\t\t\t\t\t\tIndividual plans<\/p>\n<p>\t\t\t\t\t\tGroup plans<\/p>\n<p>\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button view-all\" data-stat-paywall-cta=\"breaker view all plans\" aria-label=\"View All Plans\" rel=\"nofollow noopener\" target=\"_blank\">View All Plans<\/a><\/p>\n<p class=\"restricted-content-text\">\n\t\t\t\t\t\tTo read the rest of this story subscribe to STAT+.\t\t\t\t\t<\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button restricted-button\" data-stat-paywall-cta=\"breaker subscribe cta 1\" rel=\"nofollow noopener\" target=\"_blank\">Subscribe<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Elaine\u2019s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected&hellip;\n","protected":false},"author":2,"featured_media":62309,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[4],"tags":[1433,1400,2112,2113,8,9,1435,2400,7],"class_list":["post-62308","post","type-post","status-publish","format-standard","has-post-thumbnail","category-top-stories","tag-biotechnology","tag-cancer","tag-drug-development","tag-fda","tag-headlines","tag-news","tag-pharmaceuticals","tag-stat","tag-top-stories"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@news\/117053600803099304","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/posts\/62308","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/comments?post=62308"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/posts\/62308\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/media\/62309"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/media?parent=62308"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/categories?post=62308"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/tags?post=62308"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}