{"id":74952,"date":"2026-08-17T12:35:35","date_gmt":"2026-08-17T04:35:35","guid":{"rendered":"https:\/\/flcube.com\/?p=74952"},"modified":"2026-08-17T12:35:36","modified_gmt":"2026-08-17T04:35:36","slug":"bristol-myers-squibb-secures-fda-approval-for-iberdomide-combination-in-multiple-myeloma-first-ever-nod-based-on-mrd-negative-response-data","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=74952","title":{"rendered":"Bristol-Myers Squibb Secures FDA Approval for Iberdomide Combination in Multiple Myeloma \u2013 First\u2011Ever Nod Based on MRD\u2011Negative Response Data"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Bristol-Myers Squibb (BMS)<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/BMY:NYSE\">NYSE: BMY<\/a>) announced that the <strong>US Food and Drug Administration (FDA)<\/strong> has approved <strong>iberdomide<\/strong> in combination with <strong>subcutaneous daratumumab<\/strong> and <strong>dexamethasone<\/strong> (IberDd) for adult patients with <strong>multiple myeloma<\/strong> who have received at least one prior line of therapy, including a <strong>proteasome inhibitor<\/strong> and an <strong>immunomodulatory agent<\/strong>. The decision marks the FDA&#8217;s <strong>first\u2011ever approval in the relapsed or refractory multiple myeloma (RRMM) setting based on minimal residual disease (MRD)\u2011negative complete response data<\/strong>.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone\" class=\"wp-block-heading\">Regulatory Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Agency<\/strong><\/td><td>FDA (US)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Standard approval<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Iberdomide + subcutaneous daratumumab + dexamethasone (IberDd)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Adult multiple myeloma patients with \u22651 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent<\/td><\/tr><tr><td><strong>Announcement Date<\/strong><\/td><td>14 Aug 2026<\/td><\/tr><tr><td><strong>Basis<\/strong><\/td><td>Phase III EXCALIBER\u2011RRMM trial; first FDA approval in RRMM anchored on MRD\u2011negative CR data<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-mechanism-of-action\" class=\"wp-block-heading\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> <strong>Iberdomide<\/strong>, a novel <strong>Cereblon E3 ligase modulator (CELMoD)<\/strong><\/li>\n\n\n\n<li><strong>Class:<\/strong> New generation of <strong>targeted protein degradation therapies<\/strong><\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Modulates the cereblon E3 ligase pathway to drive selective degradation of disease\u2011relevant proteins in multiple myeloma<\/li>\n\n\n\n<li><strong>Combination Backbone:<\/strong> Paired with subcutaneous daratumumab (anti\u2011CD38 antibody) and dexamethasone in the approved regimen<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-clinical-evidence-phase-iii-excaliber-rrmm-trial\" class=\"wp-block-heading\">Clinical Evidence \u2013 Phase III EXCALIBER\u2011RRMM Trial<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Result (IberDd, n=207)<\/th><th>Comparator (DVd, n=213)<\/th><th>Relative Benefit<\/th><\/tr><\/thead><tbody><tr><td><strong>MRD\u2011Negative Complete Response Rate<\/strong><\/td><td><strong>41 %<\/strong> (n=85; 95 % CI: 34\u201348)<\/td><td>21 % (n=44; 95 % CI: 15\u201327)<\/td><td><strong>+20 ppt<\/strong>, p &lt; 0.0001<\/td><\/tr><tr><td><strong>Follow\u2011Up<\/strong><\/td><td>Median 16 months<\/td><td>Median 16 months<\/td><td>\u2013<\/td><\/tr><tr><td><strong>Statistical Significance<\/strong><\/td><td>Met one of the dual primary endpoints<\/td><td>\u2013<\/td><td>Statistically significant<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">The trial evaluated iberdomide plus subcutaneous daratumumab and dexamethasone against daratumumab, bortezomib and dexamethasone in patients with <strong>relapsed or refractory multiple myeloma<\/strong>. <strong>MRD negativity<\/strong> is a critical metric for evaluating response depth in multiple myeloma and is considered predictive of improved <strong>progression\u2011free survival (PFS)<\/strong>.<\/p>\n\n\n\n<h2 id=\"h-market-impact-amp-outlook\" class=\"wp-block-heading\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>New Drug Class:<\/strong> Iberdomide&#8217;s approval establishes CELMoD agents as a validated mechanism in multiple myeloma, broadening treatment options for patients who relapse after proteasome inhibitors and immunomodulatory agents.<\/li>\n\n\n\n<li><strong>Regulatory Precedent:<\/strong> By approving on MRD\u2011negative CR data, the FDA signals that response depth may serve as a meaningful basis for future approvals in RRMM \u2014 a potential shift in how myeloma trials are designed and evaluated.<\/li>\n\n\n\n<li><strong>Portfolio Expansion:<\/strong> The approval strengthens <strong>Bristol\u2011Myers Squibb&#8217;s<\/strong> hematology franchise with a differentiated mechanism of action in one of the most common hematologic malignancies.<\/li>\n\n\n\n<li><strong>Competitive Positioning:<\/strong> IberDd&#8217;s head\u2011to\u2011head superiority on MRD\u2011negative CR versus an active daratumumab\u2011based triplet positions the regimen as a potential new standard for second\u2011line and later therapy.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding clinical outcomes, regulatory precedent, and market expectations for iberdomide. Actual results may differ due to risks including longer\u2011term efficacy and safety data, market adoption, and competitive dynamics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Bristol-Myers Squibb (BMS) (NYSE: BMY) announced that the US Food and Drug Administration (FDA) has&#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_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[429,428,849,15,70],"class_list":["post-74952","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-bms","tag-bristol-myers-squibb","tag-nyse-bmy","tag-product-approvals","tag-tpd"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Bristol-Myers Squibb Secures FDA Approval for Iberdomide Combination in Multiple Myeloma \u2013 First\u2011Ever Nod Based on MRD\u2011Negative Response Data - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Bristol-Myers Squibb (BMS) (NYSE: BMY) announced that the US Food and Drug Administration (FDA) has approved iberdomide in combination with subcutaneous daratumumab and dexamethasone (IberDd) for adult patients with multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. 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