Paris, France | March 27, 2026
CHMP Recommends Innovative Subcutaneous Formulation
Sanofi has achieved a major regulatory milestone as the European Medicines Agency’s CHMP (Committee for Medicinal Products for Human Use) issued a positive opinion recommending approval of the subcutaneous (SC) formulation of Sarclisa (isatuximab) for the treatment of multiple myeloma (MM). This recommendation covers all currently approved indications of the intravenous (IV) version in the European Union and signals a potential shift toward more patient-friendly oncology treatments.
Notably, if approved, Sarclisa SC would become the first anticancer therapy administered via an on-body injector (OBI), offering both hands-free delivery and manual injection options, significantly improving convenience and flexibility for patients and healthcare providers. The development reflects Sanofi’s strategic push toward innovative drug delivery technologies that enhance the overall treatment experience without compromising clinical outcomes.
Clinical Data Confirms Comparable Efficacy and Safety
The CHMP recommendation is supported by robust clinical evidence, including results from the Phase 3 IRAKLIA study, which demonstrated non-inferiority of the SC formulation compared to IV infusion in patients with relapsed or refractory multiple myeloma. Key endpoints such as objective response rate (ORR) and pharmacokinetic parameters confirmed that the subcutaneous delivery maintains the strong efficacy and safety profile of the original formulation. Additional supporting studies—including GMMG-HD8 (Phase 3), IZALCO (Phase 2), and ISASOCUT (Phase 2)—further validated the clinical performance across diverse patient populations, including newly diagnosed and transplant-eligible or ineligible patients.
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Importantly, patient-reported outcomes highlighted higher satisfaction and preference for the SC on-body injector approach, emphasizing improved comfort and ease of use. The integration of Enable Injections’ enFuse® wearable device, featuring a thin, retractable needle and automated delivery system, enhances patient compliance and may reduce the burden associated with repeated hospital-based infusions.
Transforming Multiple Myeloma Treatment Experience
This advancement positions Sarclisa as a first-in-class anti-CD38 monoclonal antibody offering dual administration routes, potentially redefining standard-of-care treatment paradigms in multiple myeloma. Currently approved in more than 50 countries, Sarclisa has demonstrated significant clinical benefit across multiple lines of therapy, including newly diagnosed and relapsed/refractory settings. The introduction of a subcutaneous formulation aligns with broader industry trends toward decentralized care, home-based treatment, and improved patient quality of life. Additionally, regulatory submissions are under review in the United States, indicating a global expansion strategy for this innovative formulation.
With oncology remaining a key focus area, Sanofi continues to invest in next-generation immunotherapies and delivery systems, aiming to address high unmet needs in complex cancers while improving treatment accessibility and efficiency. The anticipated final decision from the European Commission in the coming months could mark a significant step forward in modernizing cancer care delivery across Europe.
Source: Sanofi press release
