{"success":true,"data":{"pressRelease":{"id":"68480","rtpr_id":"nGNXbmwK8R","ticker":"SASY","exchange":"Euronext Paris","all_tickers":["SASY"],"title":"Press Release: Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma","author":"Globe Newswire","published_at":"2026-06-19T10:31:11.446Z","article_body":"Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients\nwith multiple myeloma\n* Approval based on multiple studies, including the pivotal IRAKLIA phase 3\nstudy which demonstrated non-inferior efficacy and pharmacokinetics compared\nto Sarclisa IV\n* Second global approval for Sarclisa SC following the EU\nParis, June 19, 2026. The Ministry of Health, Labour and Welfare in Japan has\ngranted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in\ncombination with approved standard-of-care regimens for the treatment of\nmultiple myeloma (MM). The approved indications for Sarclisa SC in Japan\ninclude in combination with pomalidomide and dexamethasone (Pd), or with\ncarfilzomib for the treatment of relapsed or refractory MM (R/R MM) and in\ncombination with bortezomib, lenalidomide, and dexamethasone (VRd), for the\ntreatment of adult patients with newly diagnosed multiple myeloma (NDMM).\n\nA regulatory submission for the CirCLIQ on-body injector (OBI), based on the\nenFuse platform and submitted by Enable Injections, is under review in Japan.\nIf approved, Sarclisa SC could become the first anticancer treatment to be\nadministered via an OBI, and the first MM medicine in Japan to offer both\nmanual SC injection and OBI administration.\n\nIn recent years, new MM diagnoses have increased steadily in Japan, creating a\nneed for new treatment approaches particularly in the front-line setting. MM\nis the third most common hematologic malignancy in Japan.\n\n“Today’s approval of Sarclisa subcutaneous represents an important\nevolution in how we deliver care for multiple myeloma patients in\nJapan,” said Olivier Nataf, Global Head of Oncology at Sanofi. “This\nnew formulation significantly eases treatment burden and enhances convenience\nfor patients compared to intravenous administration – with the potential to\nbecome Japan's first anticancer therapy to be administered via an on-body\ninjector.”\n\nThe approval is based on results from the IRAKLIA phase 3 study in R/R MM\n(clinical study identifier: NCT05405166\n(https://clinicaltrials.gov/study/NCT05405166)), which demonstrated\nnon-inferiority of the SC formulation compared to IV, as well as supportive\nstudies\n(https://www.sanofi.com/assets/dotcom/pressreleases/2025/2025-06-03-12-26-42-3092736-en.pdf).\nIn addition to manual SC injection, these studies evaluated Sarclisa SC\nadministered through an OBI, and were conducted using Enable Injections’\nenFuse hands-free OBI, an automated injector for subcutaneous delivery of\nSarclisa.\n\nIn the IRAKLIA study, Sarclisa SC administered via an OBI in combination with\npomalidomide and dexamethasone (Pd) resulted in a 71.1% objective response\nrate (ORR), compared to 70.5% with Sarclisa IV-Pd, establishing\nnon-inferiority (risk ratio: 1.008; 95% confidence interval: 0.903-1.126;\np=0.0006), in adult patients with R/R MM who had received at least one prior\nline of treatment. The overall safety profile of Sarclisa SC-Pd observed in\nthis study was consistent with the established safety profile of Sarclisa\nIV-Pd. While 25% of patients treated with Sarclisa IV-Pd experienced\ninfusion reactions, 1.5% of patients treated with Sarclisa SC-Pd experienced\nthose reactions. No new safety concerns were observed, except for\nlow-grade local injection site reactions (ISRs) that occurred in 0.4% of OBI\ninjections (n=19/5,145 injections). Nearly all ISRs were grade 1, except for\none episode of grade 2.\n\nThe most common grade ≥3 non hematologic adverse events were pneumonia\n(14.8% OBI, 15.5% IV), COVID-19 (2.7%, 1.9%), and upper respiratory tract\ninfection (1.5% both arms). The most common grade ≥3 hematologic\nlaboratory abnormalities were neutropenia (84.7% OBI, 74.3% IV),\nthrombocytopenia (26.1%, 23%), and anemia (17.6%, 19.5%).\n\nIn Japan, Sarclisa IV is currently approved across five indications, including\nin combination with VRd in NDMM, as well as four different treatment regimens\nin R/R MM (in combination with Pd, in combination with carfilzomib and\ndexamethasone (Kd), in combination with dexamethasone alone, or as a\nmonotherapy). Sarclisa SC administered via both the CirCLIQ OBI and manual\ninjection was approved in the EU for the treatment of MM patients across all\ncurrently approved indications and combinations for Sarclisa IV formulation in\nJune 2026. An application for Sarclisa SC administered via both OBI and manual\ninjection is currently under review in the US.\n\nAbout the IRAKLIA study \nIRAKLIA (clinical study identifier: NCT05405166\n(https://www.clinicaltrials.gov/ct2/show/NCT05405166)) was a randomized,\nopen-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa\nadministered at a fixed dose SC via OBI versus weight-based dosed Sarclisa\nIV in combination with Pd in adult patients with R/R MM who have received\nat least one prior line of therapy. The co-primary outcomes assessed were ORR,\ndefined as the proportion of patients with stringent complete response (CR),\nCR, very good partial response, and partial response according to the 2016\nInternational Myeloma Working Group criteria assessed by Independent Review\nCommittee, and observed Sarclisa mean concentration before\ndosing (Ctrough) at steady state (pre-dose at cycle 6, dose 1 [C6D1]),\ndefined as observed Sarclisa plasma concentrations.\n\nAbout Enable Injections \nCincinnati-based Enable Injections is a global healthcare innovation company\ncommitted to improving the patient treatment experience through the\ndevelopment and manufacturing of the enFuse(®) On-Body Delivery System. An\ninnovative wearable technology, the enFuse system is designed to deliver large\nvolumes of pharmaceutical and biologic therapeutics via subcutaneous\nadministration, with the aim of improving convenience, supporting superior\noutcomes, and advancing healthcare system economics. For more information,\nvisit www.enableinjections.com.\n\nAbout Sarclisa\nSarclisa (isatuximab) has been approved in almost 60 countries across four\nindications for certain patients with NDMM and R/R MM. Sarclisa-based regimens\nhave been prescribed to treat more than 70,000 patients worldwide.\n\nSarclisa SC is approved in the EU and the UK in combination with approved\nstandard-of-care regimens for the treatment of patients with MM across all\ncurrently approved indications for Sarclisa IV in these countries. It is the\nfirst anticancer treatment to be administered through an OBI, and the only\nanti-CD38 monoclonal antibody available in MM to offer the flexibility of both\nSC OBI and manual injection administration.\n\nSarclisa SC is approved in Japan in combination with VRd, for the treatment of\nadult patients with NDMM, as well as Pd and Kd for the treatment of patients\nwith R/R MM.\n\nAt Sanofi, we are building on a long-standing commitment to oncology as we\ncontinue to chase the miracles of science to improve the lives of those living\nwith cancer. We are committed to transforming cancer care by developing\ninnovative, first and best-in-class immunological and targeted therapies for\nrare and difficult-to-treat cancers with high unmet need.\n\nFor more information on Sarclisa clinical studies, please\nvisit www.clinicaltrials.gov.\n\nAbout Sanofi\nSanofi is an R&D driven, AI-powered biopharma company committed to improving\npeople’s lives and delivering compelling growth. We apply our deep\nunderstanding of the immune system to invent medicines and vaccines that treat\nand protect millions of people around the world, with an innovative pipeline\nthat could benefit millions more. Our team is guided by one purpose: we\nchase the miracles of science to improve people’s lives; this inspires us to\ndrive progress and deliver positive impact for our people and the communities\nwe serve, by addressing the most urgent healthcare, environmental, and\nsocietal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ:\nSNY\n\nMedia Relations\nSandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com\nEvan Berland | +1 215 432 0234 | evan.berland@sanofi.com\nLéo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com\nVictor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com\nTimothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com\nLéa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com\nEkaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com\n\nInvestor Relations\nThomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com\nAlizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com\nKeita Browne | +1 781 249 1766 | keita.browne@sanofi.com\nNathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com\nNina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com\nThibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com\nYun Li | +33 6 84 00 90 72 | yu.li3@sanofi.com\n\nSanofi forward-looking statements \nThis press release contains forward-looking statements within the meaning of\napplicable securities laws, including the Private Securities Litigation Reform\nAct of 1995, as amended. Forward-looking statements are statements that are\nnot historical facts. These statements include projections and estimates and\ntheir underlying assumptions regarding the marketing and other potential of\nthe product; regarding potential future events and revenues from the product.\nWords such as “expect,” “anticipate,” “believe,” “intend,”\n“estimate,” “plan,” “can,” “contemplate,” “could,” “is\ndesigned to,” “may,” “might,” “potential,” “objective,”\n\"attempt,\" “target,” “project,” \"strategy,\" \"strive,\" \"desire,\"\n“predict,” “forecast,” “ambition,” “guideline,” \"seek,\"\n“should,” “will,” \"goal,\" or the negative of these and similar\nexpressions are intended to identify forward-looking statements. Although\nSanofi’s management believes that the expectations reflected in such\nforward-looking statements are reasonable, investors are cautioned that\nforward-looking information and statements are subject to various risks and\nuncertainties, many of which are difficult to predict and generally beyond the\ncontrol of Sanofi, that could cause actual results and developments to differ\nmaterially from those expressed in, or implied or projected by, the\nforward-looking information and statements. These risks, uncertainties and\nassumptions include among other things, unexpected regulatory actions or\ndelays, or government regulation generally, that could affect the availability\nor commercial potential of the product, the fact that product may not be\ncommercially successful; authorities’ decisions regarding whether and when\nto approve a product candidate; political pressure in the United States to\nmandate lower drug prices including “most favored nation” pricing for\nState Medicaid programs; the uncertainties inherent in research and\ndevelopment, including future clinical data and analysis of existing clinical\ndata relating to the product, including post marketing, unexpected safety,\nquality or manufacturing issues; competition in general; risks associated with\nintellectual property and any related pending or future litigation and the\nultimate outcome of such litigation, and volatile economic and market\nconditions, and the impact that global crises may have on us, our customers,\nsuppliers, vendors, and other business partners, and the financial condition\nof any one of them, as well as on our employees and on the global economy as a\nwhole. The risks and uncertainties also include the uncertainties discussed or\nidentified in the public filings with the SEC and the French Markets Authority\n(AMF) made by Sanofi, including those listed under “Risk Factors” and\n“Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s\nannual report on Form 20-F for the year ended December 31, 2025 or contained\nin our periodic reports on Form 6-K. Other than as required by applicable law,\nSanofi does not undertake any obligation to update or revise any\nforward-looking information or statements. In light of these risks,\nuncertainties and assumptions, you should not place undue reliance on any\nforward-looking statements contained herein.\n\nAll trademarks mentioned in this press release are the property of the Sanofi\ngroup except for enFuse and CirCLIQ.\n\nAttachment\n*     Press_Release\n(https://ml-eu.globenewswire.com/Resource/Download/d3fd4c6f-29c7-47b2-a7b0-7ba5259fa094)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/06da731a-67a1-4258-939f-6ef0531ee3bf)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXbmwK8R","title":"Press Release: Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma","author":"Globe Newswire","ticker":"SASY","created":"2026-06-19T10:31:11.446Z","tickers":["SASY"],"exchange":"Euronext Paris","article_body":"Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients\nwith multiple myeloma\n* Approval based on multiple studies, including the pivotal IRAKLIA phase 3\nstudy which demonstrated non-inferior efficacy and pharmacokinetics compared\nto Sarclisa IV\n* Second global approval for Sarclisa SC following the EU\nParis, June 19, 2026. The Ministry of Health, Labour and Welfare in Japan has\ngranted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in\ncombination with approved standard-of-care regimens for the treatment of\nmultiple myeloma (MM). The approved indications for Sarclisa SC in Japan\ninclude in combination with pomalidomide and dexamethasone (Pd), or with\ncarfilzomib for the treatment of relapsed or refractory MM (R/R MM) and in\ncombination with bortezomib, lenalidomide, and dexamethasone (VRd), for the\ntreatment of adult patients with newly diagnosed multiple myeloma (NDMM).\n\nA regulatory submission for the CirCLIQ on-body injector (OBI), based on the\nenFuse platform and submitted by Enable Injections, is under review in Japan.\nIf approved, Sarclisa SC could become the first anticancer treatment to be\nadministered via an OBI, and the first MM medicine in Japan to offer both\nmanual SC injection and OBI administration.\n\nIn recent years, new MM diagnoses have increased steadily in Japan, creating a\nneed for new treatment approaches particularly in the front-line setting. MM\nis the third most common hematologic malignancy in Japan.\n\n“Today’s approval of Sarclisa subcutaneous represents an important\nevolution in how we deliver care for multiple myeloma patients in\nJapan,” said Olivier Nataf, Global Head of Oncology at Sanofi. “This\nnew formulation significantly eases treatment burden and enhances convenience\nfor patients compared to intravenous administration – with the potential to\nbecome Japan's first anticancer therapy to be administered via an on-body\ninjector.”\n\nThe approval is based on results from the IRAKLIA phase 3 study in R/R MM\n(clinical study identifier: NCT05405166\n(https://clinicaltrials.gov/study/NCT05405166)), which demonstrated\nnon-inferiority of the SC formulation compared to IV, as well as supportive\nstudies\n(https://www.sanofi.com/assets/dotcom/pressreleases/2025/2025-06-03-12-26-42-3092736-en.pdf).\nIn addition to manual SC injection, these studies evaluated Sarclisa SC\nadministered through an OBI, and were conducted using Enable Injections’\nenFuse hands-free OBI, an automated injector for subcutaneous delivery of\nSarclisa.\n\nIn the IRAKLIA study, Sarclisa SC administered via an OBI in combination with\npomalidomide and dexamethasone (Pd) resulted in a 71.1% objective response\nrate (ORR), compared to 70.5% with Sarclisa IV-Pd, establishing\nnon-inferiority (risk ratio: 1.008; 95% confidence interval: 0.903-1.126;\np=0.0006), in adult patients with R/R MM who had received at least one prior\nline of treatment. The overall safety profile of Sarclisa SC-Pd observed in\nthis study was consistent with the established safety profile of Sarclisa\nIV-Pd. While 25% of patients treated with Sarclisa IV-Pd experienced\ninfusion reactions, 1.5% of patients treated with Sarclisa SC-Pd experienced\nthose reactions. No new safety concerns were observed, except for\nlow-grade local injection site reactions (ISRs) that occurred in 0.4% of OBI\ninjections (n=19/5,145 injections). Nearly all ISRs were grade 1, except for\none episode of grade 2.\n\nThe most common grade ≥3 non hematologic adverse events were pneumonia\n(14.8% OBI, 15.5% IV), COVID-19 (2.7%, 1.9%), and upper respiratory tract\ninfection (1.5% both arms). The most common grade ≥3 hematologic\nlaboratory abnormalities were neutropenia (84.7% OBI, 74.3% IV),\nthrombocytopenia (26.1%, 23%), and anemia (17.6%, 19.5%).\n\nIn Japan, Sarclisa IV is currently approved across five indications, including\nin combination with VRd in NDMM, as well as four different treatment regimens\nin R/R MM (in combination with Pd, in combination with carfilzomib and\ndexamethasone (Kd), in combination with dexamethasone alone, or as a\nmonotherapy). Sarclisa SC administered via both the CirCLIQ OBI and manual\ninjection was approved in the EU for the treatment of MM patients across all\ncurrently approved indications and combinations for Sarclisa IV formulation in\nJune 2026. An application for Sarclisa SC administered via both OBI and manual\ninjection is currently under review in the US.\n\nAbout the IRAKLIA study \nIRAKLIA (clinical study identifier: NCT05405166\n(https://www.clinicaltrials.gov/ct2/show/NCT05405166)) was a randomized,\nopen-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa\nadministered at a fixed dose SC via OBI versus weight-based dosed Sarclisa\nIV in combination with Pd in adult patients with R/R MM who have received\nat least one prior line of therapy. The co-primary outcomes assessed were ORR,\ndefined as the proportion of patients with stringent complete response (CR),\nCR, very good partial response, and partial response according to the 2016\nInternational Myeloma Working Group criteria assessed by Independent Review\nCommittee, and observed Sarclisa mean concentration before\ndosing (Ctrough) at steady state (pre-dose at cycle 6, dose 1 [C6D1]),\ndefined as observed Sarclisa plasma concentrations.\n\nAbout Enable Injections \nCincinnati-based Enable Injections is a global healthcare innovation company\ncommitted to improving the patient treatment experience through the\ndevelopment and manufacturing of the enFuse(®) On-Body Delivery System. An\ninnovative wearable technology, the enFuse system is designed to deliver large\nvolumes of pharmaceutical and biologic therapeutics via subcutaneous\nadministration, with the aim of improving convenience, supporting superior\noutcomes, and advancing healthcare system economics. For more information,\nvisit www.enableinjections.com.\n\nAbout Sarclisa\nSarclisa (isatuximab) has been approved in almost 60 countries across four\nindications for certain patients with NDMM and R/R MM. Sarclisa-based regimens\nhave been prescribed to treat more than 70,000 patients worldwide.\n\nSarclisa SC is approved in the EU and the UK in combination with approved\nstandard-of-care regimens for the treatment of patients with MM across all\ncurrently approved indications for Sarclisa IV in these countries. It is the\nfirst anticancer treatment to be administered through an OBI, and the only\nanti-CD38 monoclonal antibody available in MM to offer the flexibility of both\nSC OBI and manual injection administration.\n\nSarclisa SC is approved in Japan in combination with VRd, for the treatment of\nadult patients with NDMM, as well as Pd and Kd for the treatment of patients\nwith R/R MM.\n\nAt Sanofi, we are building on a long-standing commitment to oncology as we\ncontinue to chase the miracles of science to improve the lives of those living\nwith cancer. We are committed to transforming cancer care by developing\ninnovative, first and best-in-class immunological and targeted therapies for\nrare and difficult-to-treat cancers with high unmet need.\n\nFor more information on Sarclisa clinical studies, please\nvisit www.clinicaltrials.gov.\n\nAbout Sanofi\nSanofi is an R&D driven, AI-powered biopharma company committed to improving\npeople’s lives and delivering compelling growth. We apply our deep\nunderstanding of the immune system to invent medicines and vaccines that treat\nand protect millions of people around the world, with an innovative pipeline\nthat could benefit millions more. Our team is guided by one purpose: we\nchase the miracles of science to improve people’s lives; this inspires us to\ndrive progress and deliver positive impact for our people and the communities\nwe serve, by addressing the most urgent healthcare, environmental, and\nsocietal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ:\nSNY\n\nMedia Relations\nSandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com\nEvan Berland | +1 215 432 0234 | evan.berland@sanofi.com\nLéo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com\nVictor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com\nTimothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com\nLéa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com\nEkaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com\n\nInvestor Relations\nThomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com\nAlizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com\nKeita Browne | +1 781 249 1766 | keita.browne@sanofi.com\nNathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com\nNina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com\nThibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com\nYun Li | +33 6 84 00 90 72 | yu.li3@sanofi.com\n\nSanofi forward-looking statements \nThis press release contains forward-looking statements within the meaning of\napplicable securities laws, including the Private Securities Litigation Reform\nAct of 1995, as amended. Forward-looking statements are statements that are\nnot historical facts. These statements include projections and estimates and\ntheir underlying assumptions regarding the marketing and other potential of\nthe product; regarding potential future events and revenues from the product.\nWords such as “expect,” “anticipate,” “believe,” “intend,”\n“estimate,” “plan,” “can,” “contemplate,” “could,” “is\ndesigned to,” “may,” “might,” “potential,” “objective,”\n\"attempt,\" “target,” “project,” \"strategy,\" \"strive,\" \"desire,\"\n“predict,” “forecast,” “ambition,” “guideline,” \"seek,\"\n“should,” “will,” \"goal,\" or the negative of these and similar\nexpressions are intended to identify forward-looking statements. Although\nSanofi’s management believes that the expectations reflected in such\nforward-looking statements are reasonable, investors are cautioned that\nforward-looking information and statements are subject to various risks and\nuncertainties, many of which are difficult to predict and generally beyond the\ncontrol of Sanofi, that could cause actual results and developments to differ\nmaterially from those expressed in, or implied or projected by, the\nforward-looking information and statements. These risks, uncertainties and\nassumptions include among other things, unexpected regulatory actions or\ndelays, or government regulation generally, that could affect the availability\nor commercial potential of the product, the fact that product may not be\ncommercially successful; authorities’ decisions regarding whether and when\nto approve a product candidate; political pressure in the United States to\nmandate lower drug prices including “most favored nation” pricing for\nState Medicaid programs; the uncertainties inherent in research and\ndevelopment, including future clinical data and analysis of existing clinical\ndata relating to the product, including post marketing, unexpected safety,\nquality or manufacturing issues; competition in general; risks associated with\nintellectual property and any related pending or future litigation and the\nultimate outcome of such litigation, and volatile economic and market\nconditions, and the impact that global crises may have on us, our customers,\nsuppliers, vendors, and other business partners, and the financial condition\nof any one of them, as well as on our employees and on the global economy as a\nwhole. The risks and uncertainties also include the uncertainties discussed or\nidentified in the public filings with the SEC and the French Markets Authority\n(AMF) made by Sanofi, including those listed under “Risk Factors” and\n“Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s\nannual report on Form 20-F for the year ended December 31, 2025 or contained\nin our periodic reports on Form 6-K. Other than as required by applicable law,\nSanofi does not undertake any obligation to update or revise any\nforward-looking information or statements. In light of these risks,\nuncertainties and assumptions, you should not place undue reliance on any\nforward-looking statements contained herein.\n\nAll trademarks mentioned in this press release are the property of the Sanofi\ngroup except for enFuse and CirCLIQ.\n\nAttachment\n*     Press_Release\n(https://ml-eu.globenewswire.com/Resource/Download/d3fd4c6f-29c7-47b2-a7b0-7ba5259fa094)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/06da731a-67a1-4258-939f-6ef0531ee3bf)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-06-19T10:31:11.517422213Z","server_sent_at_ms":1781865071517},"received_at":"2026-06-19T10:31:11.569Z","source_url":null},"analysis":{"id":"57892","press_release_id":"68480","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"fda_approval","narrative":"Japan’s Ministry of Health, Labour and Welfare has approved the subcutaneous (SC) formulation of Sanofi’s Sarclisa (isatuximab) for multiple myeloma.\n\nThe approval covers combinations with pomalidomide/dexamethasone, carfilzomib, and VRd for both relapsed/refractory and newly diagnosed patients.\n\nApproval was based on the pivotal IRAKLIA Phase 3 study, which showed the SC formulation was non-inferior to IV with a significantly lower rate of infusion reactions (1.5% vs 25%).\n\nSanofi aims to make Sarclisa the first anticancer therapy in Japan administered via an on-body injector (OBI), pending separate regulatory review of the device by Enable Injections.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Sanofi secures Japanese approval for Sarclisa SC, expanding its oncology franchise with a differentiated, patient-friendly delivery method."},"keyFigures":{"drugName":"Sarclisa (isatuximab)","phaseOfTrial":"Phase 3","customDimensions":{"orr_iv":"70.5%","orr_sc_obi":"71.1%","global_approvals":"almost 60 countries","patients_treated":"more than 70,000","infusion_reactions_iv":"25%","infusion_reactions_sc":"1.5%","injection_site_reactions":"0.4%"}},"quotedText":"Today’s approval of Sarclisa subcutaneous represents an important evolution in how we deliver care for multiple myeloma patients in Japan","namedEntities":{"people":[{"name":"Olivier Nataf","role":"Global Head of Oncology at Sanofi"}],"products":["Sarclisa","isatuximab","CirCLIQ","enFuse"],"companies":[{"name":"Sanofi","ticker":"SASY","relationship":"filer"},{"name":"Enable Injections","relationship":"partner"},{"name":"Ministry of Health, Labour and Welfare","relationship":"regulator"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"Regulatory approval of a new subcutaneous formulation of a key oncology asset (Sarclisa) in Japan, the world's third-largest pharma market. This expands the commercial footprint of a drug already approved in ~60 countries and offers a differentiated delivery method (OBI) that reduces treatment burden. 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