{"id":15128,"date":"2023-08-15T00:41:00","date_gmt":"2023-08-14T16:41:00","guid":{"rendered":"https:\/\/flcube.com\/?p=15128"},"modified":"2024-11-27T00:45:28","modified_gmt":"2024-11-26T16:45:28","slug":"pfizers-elrexfio-earns-accelerated-fda-approval-for-relapsed-refractory-multiple-myeloma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=15128","title":{"rendered":"Pfizer&#8217;s Elrexfio Earns Accelerated FDA Approval for Relapsed\/Refractory Multiple Myeloma"},"content":{"rendered":"\n<p>This week, Pfizer (<a href=\"https:\/\/www.google.com\/finance\/quote\/PFE:NYSE\">NYSE: PFE<\/a>) received an accelerated approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Elrexfio (elranatamab) as a treatment for relapsed or refractory multiple myeloma (r\/rMM) in adults who have received at least four prior lines of therapy. The decision was based on Phase II patient response data and is contingent upon evidence of survival or symptoms improvement from confirmatory trials.<\/p>\n\n\n\n<p><strong>Elrexfio&#8217;s Mechanism of Action and Dosing<\/strong><br>Elrexfio binds CD3 on T cells, directing the lymphocytes towards BCMA expressed on multiple myeloma (MM) cells. This targeted approach offers a new option for patients with r\/rMM. The administration frequency can be reduced from once-weekly to once-biweekly for responding patients after an initial phase of 24 weeks, providing flexibility in treatment.<\/p>\n\n\n\n<p><strong>Recent Approvals in the Multiple Myeloma Space<\/strong><br>The announcement follows closely on the heels of the accelerated approval in the US of Johnson &amp; Johnson (J&amp;J; <a href=\"https:\/\/www.google.com\/finance\/quote\/JNJ:NYSE\">NYSE: JNJ<\/a>) subsidiary Janssen\u2019s GPRC5D\/CD3 BsAb Talvey (talquetamab) for a similar r\/rMM indication. This highlights the ongoing development and approval of innovative therapies for multiple myeloma, offering hope for patients with limited treatment options.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>This week, Pfizer (NYSE: PFE) received an accelerated approval from the US Food and Drug&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,150,149,28,858,863,309,15],"class_list":["post-15128","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-jj","tag-johnson-johnson","tag-multi-specific-antibodies","tag-nyse-jnj","tag-nyse-pfe","tag-pfizer","tag-product-approvals"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Pfizer&#039;s Elrexfio Earns Accelerated FDA Approval for Relapsed\/Refractory Multiple Myeloma - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"This week, Pfizer (NYSE: PFE) received an accelerated approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Elrexfio (elranatamab) as a treatment for relapsed or refractory multiple myeloma (r\/rMM) in adults who have received at least four prior lines of therapy. The decision was based on Phase II patient response data and is contingent upon evidence of survival or symptoms improvement from confirmatory trials.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=15128\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pfizer&#039;s Elrexfio Earns Accelerated FDA Approval for Relapsed\/Refractory Multiple Myeloma\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=15128\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2023-08-14T16:41:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-26T16:45:28+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=15128#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=15128\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Pfizer&#8217;s Elrexfio Earns Accelerated FDA Approval for Relapsed\\\/Refractory Multiple Myeloma\",\"datePublished\":\"2023-08-14T16:41:00+00:00\",\"dateModified\":\"2024-11-26T16:45:28+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=15128\"},\"wordCount\":211,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Cancer\",\"J&amp;J\",\"Johnson &amp; Johnson\",\"Multi-specific antibodies\",\"NYSE: JNJ\",\"NYSE: PFE\",\"Pfizer\",\"Product approvals\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=15128#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=15128\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=15128\",\"name\":\"Pfizer's Elrexfio Earns Accelerated FDA Approval for Relapsed\\\/Refractory Multiple Myeloma - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-08-14T16:41:00+00:00\",\"dateModified\":\"2024-11-26T16:45:28+00:00\",\"description\":\"This week, Pfizer (NYSE: PFE) received an accelerated approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Elrexfio (elranatamab) as a treatment for relapsed or refractory multiple myeloma (r\\\/rMM) in adults who have received at least four prior lines of therapy. The decision was based on Phase II patient response data and is contingent upon evidence of survival or symptoms improvement from confirmatory trials.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=15128#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=15128\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=15128#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Pfizer&#8217;s Elrexfio Earns Accelerated FDA Approval for Relapsed\\\/Refractory Multiple Myeloma\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Pfizer's Elrexfio Earns Accelerated FDA Approval for Relapsed\/Refractory Multiple Myeloma - Insight, China&#039;s Pharmaceutical Industry","description":"This week, Pfizer (NYSE: PFE) received an accelerated approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Elrexfio (elranatamab) as a treatment for relapsed or refractory multiple myeloma (r\/rMM) in adults who have received at least four prior lines of therapy. The decision was based on Phase II patient response data and is contingent upon evidence of survival or symptoms improvement from confirmatory trials.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=15128","og_locale":"en_US","og_type":"article","og_title":"Pfizer's Elrexfio Earns Accelerated FDA Approval for Relapsed\/Refractory Multiple Myeloma","og_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","og_url":"https:\/\/flcube.com\/?p=15128","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-08-14T16:41:00+00:00","article_modified_time":"2024-11-26T16:45:28+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=15128#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=15128"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Pfizer&#8217;s Elrexfio Earns Accelerated FDA Approval for Relapsed\/Refractory Multiple Myeloma","datePublished":"2023-08-14T16:41:00+00:00","dateModified":"2024-11-26T16:45:28+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=15128"},"wordCount":211,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Cancer","J&amp;J","Johnson &amp; Johnson","Multi-specific antibodies","NYSE: JNJ","NYSE: PFE","Pfizer","Product approvals"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=15128#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=15128","url":"https:\/\/flcube.com\/?p=15128","name":"Pfizer's Elrexfio Earns Accelerated FDA Approval for Relapsed\/Refractory Multiple Myeloma - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-08-14T16:41:00+00:00","dateModified":"2024-11-26T16:45:28+00:00","description":"This week, Pfizer (NYSE: PFE) received an accelerated approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Elrexfio (elranatamab) as a treatment for relapsed or refractory multiple myeloma (r\/rMM) in adults who have received at least four prior lines of therapy. The decision was based on Phase II patient response data and is contingent upon evidence of survival or symptoms improvement from confirmatory trials.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=15128#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=15128"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=15128#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Pfizer&#8217;s Elrexfio Earns Accelerated FDA Approval for Relapsed\/Refractory Multiple Myeloma"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/15128","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=15128"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/15128\/revisions"}],"predecessor-version":[{"id":15129,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/15128\/revisions\/15129"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15128"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=15128"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=15128"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}