{"id":30765,"date":"2022-06-14T17:46:00","date_gmt":"2022-06-14T09:46:00","guid":{"rendered":"https:\/\/flcube.com\/?p=30765"},"modified":"2025-03-27T17:51:33","modified_gmt":"2025-03-27T09:51:33","slug":"beigenes-brukinsa-faces-three-month-fda-approval-delay-for-cll-sll-indication","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=30765","title":{"rendered":"BeiGene&#8217;s Brukinsa Faces Three-Month FDA Approval Delay for CLL\/SLL Indication"},"content":{"rendered":"\n<p>China-based biotech company BeiGene Inc. (Nasdaq: BGNE) will experience a three-month delay in its pursuit of US approval for its Bruton\u2019s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL\/SLL). The US Food and Drug Administration (FDA) has pushed back the Prescription Drug User Fee Act (PDUFA) goal date to January 20, 2023, to review new data submitted by BeiGene in support of its supplementary new drug application (sNDA).<\/p>\n\n\n\n<p><strong>New Data from ALPINE Study<\/strong><br>The additional data comes from the global ALPINE study, which demonstrated Brukinsa&#8217;s superiority over ibrutinib with an overall response rate (ORR) of 80.4% versus 72.9% in adult patients with relapsed or refractory (R\/R) CLL\/SLL, as assessed by an Independent Review Committee (IRC). The study included 652 patients across sites in Europe and the US, among other locations, and is ongoing with plans to analyze other key secondary endpoints such as progression-free survival (PFS).<\/p>\n\n\n\n<p><strong>Current US Approvals and Future Outlook<\/strong><br>Brukinsa is already approved in the US for smaller indications including Waldenstrom&#8217;s macroglobulinemia (WM), mantle-cell lymphoma (MCL), and marginal zone lymphoma (MZL). Industry watchers expect eventual approval for CLL\/SLL, especially since the US National Comprehensive Cancer Network has endorsed Brukinsa as a treatment for CLL\/SLL in its latest guidelines.<\/p>\n\n\n\n<p><strong>International Approvals<\/strong><br>In a separate announcement, BeiGene revealed that Brukinsa has received market approvals to treat MCL in Kuwait, Bahrain, and Qatar, marking further progress for the drug in international markets.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China-based biotech company BeiGene Inc. (Nasdaq: BGNE) will experience a three-month delay in its pursuit&#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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[185,2092,16,15],"class_list":["post-30765","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-beigene","tag-beone-medicines","tag-cancer","tag-product-approvals"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>BeiGene&#039;s Brukinsa Faces Three-Month FDA Approval Delay for CLL\/SLL Indication - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based biotech company BeiGene Inc. (Nasdaq: BGNE) will experience a three-month delay in its pursuit of US approval for its Bruton\u2019s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL\/SLL). The US Food and Drug Administration (FDA) has pushed back the Prescription Drug User Fee Act (PDUFA) goal date to January 20, 2023, to review new data submitted by BeiGene in support of its supplementary new drug application (sNDA).\" \/>\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=30765\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BeiGene&#039;s Brukinsa Faces Three-Month FDA Approval Delay for CLL\/SLL Indication\" \/>\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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