{"id":14723,"date":"2023-08-24T22:22:00","date_gmt":"2023-08-24T14:22:00","guid":{"rendered":"https:\/\/flcube.com\/?p=14723"},"modified":"2024-11-24T22:25:42","modified_gmt":"2024-11-24T14:25:42","slug":"fda-grants-priority-review-to-pfizer-and-astellas-xtandi-for-high-risk-prostate-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=14723","title":{"rendered":"FDA Grants Priority Review to Pfizer and Astellas&#8217; Xtandi for High-Risk Prostate Cancer"},"content":{"rendered":"\n<p>The US Food and Drug Administration (FDA) has granted priority review status to the submission by pharmaceutical partners Pfizer (<a href=\"https:\/\/www.google.com\/finance\/quote\/PFE:NYSE\">NYSE: PFE<\/a>) and Astellas (<a href=\"https:\/\/www.google.com\/finance\/quote\/4503:TYO\">TYO: 4503<\/a>) for their drug combination of Xtandi (enzalutamide) and leuprolide. This treatment is intended for patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) who are at high risk of biochemical recurrence (BCR). The FDA anticipates making a decision on the treatment during the fourth quarter of 2023. This expedited review process is facilitated by Project Orbis, an initiative that enables concurrent submission and review of oncology drugs by international regulatory partners.<\/p>\n\n\n\n<p><strong>Phase III Data Supports Filing, Demonstrating Reduced Risk of Metastasis or Death<\/strong><br>The filing for Xtandi in combination with leuprolide is supported by robust Phase III clinical trial data. These data indicate that the addition of Xtandi to leuprolide therapy reduced the risk of metastasis or death by 58% in patients with nmCSPC. Moreover, the safety profile of the combined treatment was found to be consistent with that of each individual molecule, providing confidence in the tolerability of the therapy.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The US Food and Drug Administration (FDA) has granted priority review status to the submission&#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":[353,16,38,863,309,80,1177],"class_list":["post-14723","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-astellas-pharma","tag-cancer","tag-market-approval-filings","tag-nyse-pfe","tag-pfizer","tag-priority-reviews","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 Grants Priority Review to Pfizer and Astellas&#039; Xtandi for High-Risk Prostate Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The US Food and Drug Administration (FDA) has granted priority review status to the submission by pharmaceutical partners Pfizer (NYSE: PFE) and Astellas (TYO: 4503) for their drug combination of Xtandi (enzalutamide) and leuprolide. This treatment is intended for patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) who are at high risk of biochemical recurrence (BCR). The FDA anticipates making a decision on the treatment during the fourth quarter of 2023. This expedited review process is facilitated by Project Orbis, an initiative that enables concurrent submission and review of oncology drugs by international regulatory partners.\" \/>\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=14723\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Grants Priority Review to Pfizer and Astellas&#039; Xtandi for High-Risk Prostate 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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