{"id":35731,"date":"2026-07-20T17:24:00","date_gmt":"2026-07-20T11:54:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=35731"},"modified":"2026-07-20T13:25:19","modified_gmt":"2026-07-20T07:55:19","slug":"sanofi-sarclisa-escena-approval","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/sanofi-sarclisa-escena-approval","title":{"rendered":"Sanofi&#8217;s SARCLISA ESCENA Makes History as the First Wearable Cancer Treatment"},"content":{"rendered":"\n<p><strong><em>Summary<\/em><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em>SARCLISA ESCENA is the first anticancer treatment approved for delivery via an on-body injector \u2014 approved in the US, EU, and UK.<\/em><\/li>\n\n\n\n<li><em>It&#8217;s delivered via CirCLIQ, a hands-free wearable device built on Enable Injections&#8217; enFuse platform.<\/em><\/li>\n\n\n\n<li><em>Approval was supported by the Phase 3 IRAKLIA trial, showing efficacy, safety, and pharmacokinetics comparable to IV SARCLISA, with less time in treatment and fewer infusion reactions.<\/em><\/li>\n\n\n\n<li><em>The approval strengthens Sanofi&#8217;s competitive footing against DARZALEX and reflects a broader shift toward take-home, low-burden cancer care.<\/em><\/li>\n<\/ul>\n\n\n\n<p>For decades, cancer treatment has meant one thing for most patients: the infusion chair. Hours tethered to an IV line, repeated clinic visits, and the quiet toll that comes with it. That picture just changed. On July 10, 2026, the US FDA approved <strong>SARCLISA ESCENA<\/strong>, Sanofi&#8217;s subcutaneous formulation of isatuximab-irfc, making it the first anticancer treatment in history cleared for administration through an on-body injector (OBI). The approval follows on the heels of SARCLISA&#8217;s subcutaneous nod in the European Union on June 8, 2026, where it likewise became the first OBI-delivered cancer therapy in that market, as well as clearance in the UK.<\/p>\n\n\n\n<p>With this trio of approvals, SARCLISA becomes the only <a href=\"https:\/\/www.delveinsight.com\/blog\/cd38-directed-therapies-for-multiple-myeloma-treatment\">anti-CD38 monoclonal antibody in multiple myeloma<\/a> that patients and providers can choose to administer two ways: through the automated CirCLIQ wearable device, or via a traditional manual subcutaneous injection. CirCLIQ is a hands-free, automated on-body injector built on Enable Injections&#8217; enFuse platform. The device uses a retractable 30-gauge needle, notably thinner and shorter than the needles typically required for high-volume biologic injections, and is designed to be worn on the body while it delivers the full dose automatically.<\/p>\n\n\n\n<p>SARCLISA is approved in the US for three indications across the <a href=\"https:\/\/www.delveinsight.com\/blog\/multiple-myeloma-treatment\">multiple myeloma treatment landscape<\/a>. In newly diagnosed multiple myeloma (NDMM), it is indicated in combination with bortezomib, lenalidomide, and dexamethasone for patients who are ineligible for autologous stem cell transplantation. For relapsed\/refractory multiple myeloma, SARCLISA is approved in combination with pomalidomide and dexamethasone (Pd) for patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and whose disease has relapsed following their most recent treatment. It is also approved in combination with carfilzomib and dexamethasone for patients who have undergone one to three prior lines of therapy.<\/p>\n\n\n\n<p>The new approval doesn&#8217;t introduce a new indication; instead, it extends every indication already approved for the IV formulation to this more convenient delivery format, covering combinations with standard-of-care regimens such as pomalidomide and dexamethasone. Regulatory approval didn&#8217;t come from convenience alone; it was backed by robust clinical data from the pivotal <strong>Phase 3 IRAKLIA study<\/strong>.&nbsp;<\/p>\n\n\n\n<p>In the Phase III IRAKLIA trial, the first study to evaluate an on-body injector for the <a href=\"https:\/\/www.delveinsight.com\/blog\/bms-and-janssen-multiple-myeloma-treatment-drugs\">treatment of multiple myeloma<\/a>, subcutaneous (SC) SARCLISA administered via an OBI in combination with pomalidomide and dexamethasone (Pd) demonstrated an objective response rate (ORR) of 71.1% (187\/263). This was comparable to the 70.5% ORR (189\/268) achieved with intravenous (IV) SARCLISA plus Pd, meeting the predefined criteria for non-inferiority (relative risk: 1.008; 95% confidence interval: 0.903\u20131.126). The study enrolled adults with relapsed or refractory multiple myeloma (R\/R MM) who had received at least one prior line of therapy.<\/p>\n\n\n\n<div dir=\"ltr\" align=\"left\">\n<table style=\"border-collapse: collapse; width: 77.5434%; height: 519.104px; border: 1px solid #000000;\" border=\"1\"><colgroup><col style=\"width: 20.8222%;\" width=\"130\"><col style=\"width: 25.7875%;\" width=\"161\"><col style=\"width: 25.307%;\" width=\"158\"><col style=\"width: 28.0299%;\" width=\"175\"><\/colgroup>\n<tbody>\n<tr style=\"height: 67.8542px; background-color: #d7e9ff;\">\n<td style=\"border-width: 1px; border-color: #000000;\" colspan=\"4\">\n<p dir=\"ltr\" style=\"text-align: center;\"><strong>Operational Comparison: IV Infusion, Manual SC, CirCLIQ Device<\/strong><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 90.25px; background-color: #f8f8f8;\">\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\">&nbsp;<\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\"><strong>IV infusion<\/strong><\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\"><strong>Manual SC injection<\/strong><\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\"><strong>CirCLIQ on-body injector<\/strong><\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 90.25px; background-color: #f8f8f8;\">\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\"><strong>Administration time<\/strong><\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\">Several hours per session<\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\">A few minutes, manual push<\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\">Minutes, hands-free delivery<\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 90.25px; background-color: #f8f8f8;\">\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\"><strong>Who administers<\/strong><\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\">Nurse, continuous monitoring<\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\">Nurse pushes syringe manually<\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\">Automated device, light oversight<\/p>\n<\/td>\n<\/tr>\n<tr style=\"height: 90.25px; background-color: #f8f8f8;\">\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\"><strong>Care setting<\/strong><\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\">Infusion center only<\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\">Clinic or outpatient setting<\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\">Clinic, outpatient, or home-eligible<\/p>\n<\/td>\n<\/tr>\n<tr style=\"background-color: #f8f8f8; height: 90.25px;\">\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\"><strong>Physical burden on staff<\/strong><\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\">High, extended monitoring<\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\">High, forceful syringe push<\/p>\n<\/td>\n<td style=\"border-width: 1px; border-color: #000000;\">\n<p dir=\"ltr\">Low, wearable does the work<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p>\n\n\n\n<p>The safety profile of SARCLISA SC-Pd was generally consistent with that of the IV formulation. Systemic administration-related reactions occurred in only 1.5% of patients receiving the SC regimen, compared with 25% of those treated with IV SARCLISA-Pd. No unexpected safety signals were identified, apart from injection-site reactions (ISRs), which were reported in 0.4% of OBI administrations (19 events across 5,145 injections). Almost all ISRs were mild (Grade 1), with only a single Grade 2 event reported.<\/p>\n\n\n\n<p>The most frequently reported adverse events (occurring in \u226520% of patients) included upper respiratory tract infections, fatigue, pneumonia, musculoskeletal pain, and diarrhea. Common hematologic laboratory abnormalities (\u226540%) comprised reduced leukocyte, neutrophil, lymphocyte, platelet, and hemoglobin levels.<\/p>\n\n\n\n<p><em>Sikander Ailawadhi, MD, Professor of Medicine, Division of Hematology\/Oncology at Mayo Clinic Florida, US, and principal investigator of the IRAKLIA study, highlighted the challenges associated with current multiple myeloma treatment, which typically requires frequent IV infusions or manual subcutaneous injections. He emphasized that these administration methods can be inconvenient for patients and physically demanding for healthcare providers, particularly when high-resistance syringes must be manually pushed over several minutes. He added that the on-body injector (OBI), backed by consistent efficacy across multiple clinical studies, could enhance the patient experience while preserving SARCLISA&#8217;s proven therapeutic effectiveness.<\/em><\/p>\n\n\n\n<p>SARCLISA isn&#8217;t the first anti-CD38 therapy to reach the market; Johnson &amp; Johnson&#8217;s DARZALEX got there five years earlier and has dominated the space, generating roughly <strong>$14.4 billion<\/strong> in 2025 sales alone, with its own subcutaneous version, <a href=\"https:\/\/www.delveinsight.com\/blog\/darzalex-faspro-regimen-for-multiple-myeloma\">DARZALEX FASPRO<\/a>, already approved since 2020. SARCLISA, by comparison, posted around <strong>\u20ac588 million<\/strong> in 2025 sales, though growing at a faster clip.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"289\" src=\"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/07\/SARCLISA-ESCENA-Roadmap-1024x289.webp\" alt=\"SARCLISA-ESCENA-Roadmap\" class=\"wp-image-35736\" srcset=\"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/07\/SARCLISA-ESCENA-Roadmap-1024x289.webp 1024w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/07\/SARCLISA-ESCENA-Roadmap-300x85.webp 300w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/07\/SARCLISA-ESCENA-Roadmap-150x42.webp 150w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/07\/SARCLISA-ESCENA-Roadmap-768x217.webp 768w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/07\/SARCLISA-ESCENA-Roadmap-1536x434.webp 1536w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/07\/SARCLISA-ESCENA-Roadmap.webp 1920w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>That&#8217;s precisely why the on-body injector matters strategically, not just clinically. Sanofi now offers something Darzalex doesn&#8217;t: an anticancer therapy that patients can receive through a wearable, automated device, not just a manual subcutaneous shot.&nbsp;<\/p>\n\n\n\n<p><em>Manuela Buxo, Executive Vice President and Head of Specialty Care at Sanofi, stated that SARCLISA serves as the foundation of the company&#8217;s oncology portfolio and has consistently demonstrated its potential to become a leading therapy in its class. She noted that the approval of the subcutaneous formulation, SARCLISA ESCENA, delivered through the CirCLIQ on-body delivery system, marks a significant milestone toward expanding patient access. According to Buxo, more than 70,000 patients globally have been treated with SARCLISA, which has shown consistent efficacy and a well-established safety profile across multiple treatment combinations and lines of therapy. She added that this innovation is designed to help physicians improve the treatment experience by providing a simpler, more flexible, and more convenient administration option for patients.<\/em><\/p>\n\n\n\n<p>The US and EU approvals aren&#8217;t isolated wins; they&#8217;re part of a broader global expansion of Sanofi&#8217;s isatuximab franchise. SARCLISA SC is now approved in the US, EU, and UK, with additional regulatory submissions under review in markets including China and Japan (where the manual SC formulation is already approved and the OBI submission is pending). To date, SARCLISA-based regimens have been prescribed to nearly 70,000 patients worldwide, underscoring how deeply the therapy is already embedded in <a href=\"https:\/\/www.delveinsight.com\/blog\/multiple-myeloma-market\">multiple myeloma treatment protocols<\/a>.<\/p>\n\n\n\n<p><strong>Enable Injections<\/strong>, the Cincinnati-based company behind the CirCLIQ\/enFuse technology, isn&#8217;t new to wearable drug delivery; its <strong>enFuse device<\/strong> earned its first FDA approval roughly three years ago to administer <strong>Apellis Pharmaceuticals&#8217; EMPAVELI<\/strong> for paroxysmal nocturnal hemoglobinuria. But SARCLISA ESCENA marks the platform&#8217;s first entry into oncology, and the first time any anticancer therapy has used an on-body injector at all.<\/p>\n\n\n\n<p>That&#8217;s a notable inflection point for the broader biologics space. On-body injectors have been gaining traction as a way to deliver higher-volume drug formulations without the infrastructure and time demands of IV infusion. Oncology, with its complex, high-volume biologic regimens and heavily burdened patients, is a natural, if late, frontier for this technology. SARCLISA ESCENA&#8217;s approval may well open the door for other cancer or <a href=\"https:\/\/www.delveinsight.com\/blog\/emerging-multiple-myeloma-therpies-in-clinical-trials\">multiple myeloma therapies<\/a> to pursue similar delivery innovations.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/www.delveinsight.com\/report-store\/multiple-myeloma-market\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"194\" src=\"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/05\/Multiple-Myeloma-Market-Assessment-1024x194.webp\" alt=\"Multiple Myeloma Market Assessment\" class=\"wp-image-35255\" srcset=\"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/05\/Multiple-Myeloma-Market-Assessment-1024x194.webp 1024w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/05\/Multiple-Myeloma-Market-Assessment-300x57.webp 300w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/05\/Multiple-Myeloma-Market-Assessment-150x28.webp 150w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/05\/Multiple-Myeloma-Market-Assessment-768x145.webp 768w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/05\/Multiple-Myeloma-Market-Assessment-1536x291.webp 1536w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/05\/Multiple-Myeloma-Market-Assessment.webp 1584w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Summary For decades, cancer treatment has meant one thing for most patients: the infusion chair. Hours tethered to an IV line, repeated clinic visits, and the quiet toll that comes with it. That picture just changed. On July 10, 2026, the US FDA approved SARCLISA ESCENA, Sanofi&#8217;s subcutaneous formulation of isatuximab-irfc, making it the first [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":35734,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[21239,22218,410,16671,19906,16672,21241,23049],"industry":[17225],"therapeutic_areas":[17228],"class_list":["post-35731","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-cd38-directed-therapies","tag-darzalex-faspro","tag-multiple-myeloma","tag-multiple-myeloma-pipeline","tag-multiple-myeloma-treatment","tag-multiple-myeloma-treatment-market","tag-sarclisa","tag-sarclisa-escena","industry-pharmaceutical","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.9 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Sanofi\u2019s SARCLISA ESCENA Redefines Multiple Myeloma Space<\/title>\n<meta name=\"description\" content=\"In July 2026, FDA approved SARCLISA ESCENA making it first anticancer treatment in history cleared for administration through OBI.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/sanofi-sarclisa-escena-approval\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sanofi\u2019s SARCLISA ESCENA Redefines Multiple Myeloma Space\" \/>\n<meta property=\"og:description\" content=\"In July 2026, FDA approved SARCLISA ESCENA making it first anticancer treatment in history cleared for administration through OBI.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/sanofi-sarclisa-escena-approval\" \/>\n<meta property=\"og:site_name\" content=\"DelveInsight Business Research\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-07-20T11:54:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/07\/sanofi-sarclisa-escena-approval.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"466\" \/>\n\t<meta property=\"og:image:height\" content=\"284\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"Sandeep Joshi\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:site\" content=\"@DelveInsight\" \/>\n<meta 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