{"id":16082,"date":"2016-08-31T15:40:16","date_gmt":"2016-08-31T13:40:16","guid":{"rendered":"http:\/\/mabdesign.fr\/fda-approves-genmabs-arzerra-ofatumumab\/"},"modified":"2025-01-09T09:58:15","modified_gmt":"2025-01-09T08:58:15","slug":"fda-approves-genmabs-arzerra-ofatumumab","status":"publish","type":"post","link":"https:\/\/mabdesign.fr\/en\/fda-approves-genmabs-arzerra-ofatumumab\/","title":{"rendered":"FDA approves Genmab&#8217;s Arzerra\u00ae (ofatumumab)"},"content":{"rendered":"<p style=\"text-align: justify;\">Genmab A\/S\u00a0 announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra\u00ae) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). The application, which received Priority Review in May 2016, was submitted to the FDA by Novartis under the ofatumumab collaboration between Novartis and Genmab.<\/p>\n<p style=\"text-align: justify;\">Approval for this indication by the FDA is based on results from the Phase III COMPLEMENT 2 study that evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL. Top-line results from COMPLEMENT 2 were reported in April 2015.<\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"http:\/\/ir.genmab.com\/releasedetail.cfm?ReleaseID=987180\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #6aa336;\">READ MORE<\/span><\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Genmab A\/S  announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra\u00ae).<\/p>\n","protected":false},"author":1,"featured_media":8453,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-16082","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-non-classifiee"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA approves Genmab&#039;s Arzerra\u00ae (ofatumumab) - MabDesign<\/title>\n<meta name=\"description\" content=\"Genmab A\/S announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra\u00ae).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mabdesign.fr\/en\/fda-approves-genmabs-arzerra-ofatumumab\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA approves Genmab&#039;s Arzerra\u00ae (ofatumumab) - MabDesign\" \/>\n<meta property=\"og:description\" content=\"Genmab A\/S announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra\u00ae).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/mabdesign.fr\/en\/fda-approves-genmabs-arzerra-ofatumumab\/\" \/>\n<meta property=\"og:site_name\" content=\"MabDesign\" \/>\n<meta property=\"article:published_time\" content=\"2016-08-31T13:40:16+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-01-09T08:58:15+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/mabdesign.fr\/wp-content\/uploads\/2023\/10\/Genmab.svg.png\" \/>\n\t<meta property=\"og:image:width\" content=\"640\" \/>\n\t<meta property=\"og:image:height\" content=\"187\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"alexis.mathias@kairios.fr\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@MabDesign_fr\" \/>\n<meta name=\"twitter:site\" content=\"@MabDesign_fr\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"alexis.mathias@kairios.fr\" \/>\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:\/\/mabdesign.fr\/en\/fda-approves-genmabs-arzerra-ofatumumab\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/mabdesign.fr\/en\/fda-approves-genmabs-arzerra-ofatumumab\/\"},\"author\":{\"name\":\"alexis.mathias@kairios.fr\",\"@id\":\"https:\/\/mabdesign.fr\/en\/#\/schema\/person\/0a9d0510f7433c83f9e6974b2a9c0135\"},\"headline\":\"FDA approves Genmab&#8217;s Arzerra\u00ae (ofatumumab)\",\"datePublished\":\"2016-08-31T13:40:16+00:00\",\"dateModified\":\"2025-01-09T08:58:15+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/mabdesign.fr\/en\/fda-approves-genmabs-arzerra-ofatumumab\/\"},\"wordCount\":119,\"publisher\":{\"@id\":\"https:\/\/mabdesign.fr\/en\/#organization\"},\"image\":{\"@id\":\"https:\/\/mabdesign.fr\/en\/fda-approves-genmabs-arzerra-ofatumumab\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/mabdesign.fr\/wp-content\/uploads\/2023\/10\/Genmab.svg.png\",\"articleSection\":[\"Non classifi\u00e9(e)\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/mabdesign.fr\/en\/fda-approves-genmabs-arzerra-ofatumumab\/\",\"url\":\"https:\/\/mabdesign.fr\/en\/fda-approves-genmabs-arzerra-ofatumumab\/\",\"name\":\"FDA approves Genmab's Arzerra\u00ae (ofatumumab) - 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