{"id":10666,"date":"2023-12-18T21:00:00","date_gmt":"2023-12-18T13:00:00","guid":{"rendered":"https:\/\/flcube.com\/?p=10666"},"modified":"2024-12-10T10:49:02","modified_gmt":"2024-12-10T02:49:02","slug":"fda-approves-pfizer-astellas-msd-combo-therapy-for-advanced-urothelial-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=10666","title":{"rendered":"FDA Approves Pfizer-Astellas-MSD Combo Therapy for Advanced Urothelial Cancer"},"content":{"rendered":"\n<p>Pfizer (<a href=\"https:\/\/www.google.com\/finance\/quote\/PFE:NYSE\">NYSE: PFE<\/a>), Astellas (<a href=\"https:\/\/www.google.com\/finance\/quote\/4503:TYO\">TYO: 4503<\/a>), and Merck, Sharp &amp; Dohme (MSD; <a href=\"https:\/\/www.google.com\/finance\/quote\/MRK:NYSE\">NYSE: MRK<\/a>) have secured U.S. Food and Drug Administration (FDA) approval for their combination therapy consisting of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) for the treatment of locally advanced or metastatic urothelial cancer (la\/mUC). The FDA&#8217;s decision is supported by data from a late-stage study showing that the dual therapy nearly doubled median overall survival (OS) and median progression-free survival (PFS) compared to chemotherapy.<\/p>\n\n\n\n<p>This data will be instrumental in bolstering global regulatory submissions and in converting the conditional approval for adult patients with la\/mUC who are ineligible for cisplatin-containing chemotherapy into a full approval.<\/p>\n\n\n\n<p>The successful pairing stems from a collaboration agreement between MSD and partners Astellas and Pfizer-acquired Seagen, focusing on untreated metastatic urothelial cancer.- <a href=\"https:\/\/flcube.com\">Flcube.com<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pfizer (NYSE: PFE), Astellas (TYO: 4503), and Merck, Sharp &amp; Dohme (MSD; NYSE: MRK) have&#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":[16,29,120,2675,176,903,863,309,15,1177],"class_list":["post-10666","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-combination-therapy","tag-merck","tag-merck-sharp-dohme","tag-msd","tag-nyse-mrk","tag-nyse-pfe","tag-pfizer","tag-product-approvals","tag-tyo-4503"],"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>FDA Approves Pfizer-Astellas-MSD Combo Therapy for Advanced Urothelial Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Pfizer (NYSE: PFE), Astellas (TYO: 4503), and Merck, Sharp &amp; Dohme (MSD; NYSE: MRK) have secured U.S. Food and Drug Administration (FDA) approval for their combination therapy consisting of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) for the treatment of locally advanced or metastatic urothelial cancer (la\/mUC). The FDA&#039;s decision is supported by data from a late-stage study showing that the dual therapy nearly doubled median overall survival (OS) and median progression-free survival (PFS) compared to chemotherapy.\" \/>\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=10666\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Approves Pfizer-Astellas-MSD Combo Therapy for Advanced Urothelial Cancer\" \/>\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. 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