{"id":16084,"date":"2016-09-07T15:55:30","date_gmt":"2016-09-07T13:55:30","guid":{"rendered":"http:\/\/mabdesign.fr\/fda-accepts-sbla-to-msds-keytruda-pembrolizumab\/"},"modified":"2025-01-09T09:57:31","modified_gmt":"2025-01-09T08:57:31","slug":"fda-accepts-sbla-to-msds-keytruda-pembrolizumab","status":"publish","type":"post","link":"https:\/\/mabdesign.fr\/en\/fda-accepts-sbla-to-msds-keytruda-pembrolizumab\/","title":{"rendered":"FDA accepts sBLA to MSD&#8217;s KEYTRUDA\u00ae (pembrolizumab)"},"content":{"rendered":"<p style=\"text-align: justify;\">Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA<sup>\u00ae <\/sup>(pembrolizumab), the company\u2019s anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, with a PDUFA, or target action, date of Dec. 24, 2016. Additionally, the FDA granted Breakthrough Therapy Designation for this indication. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency for this indication.<\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"http:\/\/www.mercknewsroom.com\/news-release\/oncology-newsroom\/fda-accepts-supplemental-biologics-license-application-assigns-priori\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #6aa336;\">READ MORE<\/span><\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA\u00ae (pembrolizumab).<\/p>\n","protected":false},"author":1,"featured_media":8459,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-16084","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 - 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