Written By: Anand Sathappan, BPharm
Reviewed By: Pharmacally Editorial Team
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Sarclisa (isatuximab) subcutaneous (SC) formulation for patients with multiple myeloma (MM).
If approved, the SC version of Sarclisa developed by Sanofi would be available across all currently approved intravenous (IV) indications. It could become the first anticancer therapy to offer both an on-body injector (OBI) and manual injection options, and the only anti-CD38 monoclonal antibody with this dual delivery flexibility in MM.
The recommendation is primarily supported by results from the Phase 3 IRAKLIA trial (NCT05405166), which demonstrated that the SC formulation is non-inferior to the IV version in patients with relapsed or refractory multiple myeloma. Additional supporting evidence came from multiple studies, including the Phase 3 GMMG-HD8 trial (NCT05804032) and Phase 2 IZALCO (NCT05704049) and ISASOCUT studies (NCT05889221), along with a Phase 1b study in heavily pretreated patients.
Across these studies, Sarclisa SC maintained a comparable efficacy and safety profile to the IV formulation. Patient-reported outcomes showed higher satisfaction with SC administration, particularly when delivered via the OBI. Both patients and healthcare providers also expressed preference for the OBI over manual injection, highlighting potential improvements in treatment experience and convenience.
The SC formulation is administered using the enFuse® on-body delivery system developed by Enable Injections. This wearable injector is designed for high-volume subcutaneous delivery and features a thinner, retractable needle, which may enhance patient comfort compared to traditional infusion methods.
Sarclisa IV is already approved in the EU across multiple lines of therapy in both newly diagnosed and relapsed/refractory MM. A regulatory submission for the SC formulation is also under review by the U.S. Food and Drug Administration.
While the CHMP opinion represents a significant milestone, Sarclisa SC whether delivered via OBI or manual injection remains investigational until final regulatory approval is granted. A formal decision from the European Commission is expected in the coming months.
Reference
Press Release: Sanofi’s Sarclisa subcutaneous formulation administered via on-body injector recommended for EU approval by the CHMP to treat multiple myeloma, 27 March 2026, Press Release: Sanofi’s Sarclisa subcutaneous formulation administered via on-body injector recommended for EU approval by the CHMP to treat multiple myeloma
SC Versus IV Isatuximab in Combination with Pomalidomide and Dexamethasone in RRMM (IRAKLIA), ClinicalTrials.gov ID NCT05405166, https://clinicaltrials.gov/study/NCT05405166
About the Writer
Anand Sathappan is a pharmacy graduate with interests in pharmaceutical sciences, pharmacology, and medical writing. He also holds certification in medical coding and has familiarity with pharmacology and healthcare documentation. He has completed the Medical Writing Skills for Beginners program offered by the International Medical Writers Association (IMWA). His work focuses on exploring developments in pharmaceuticals and presenting scientific information in a clear and structured manner.