Sanofi (SNY) announced that the European Commission has granted clearance for Sarclisa (isatuximab) subcutaneous (SC) in combination with standard-of-care (SOC) regimens across all existing indications for Sarclisa intravenous (IV) formulation.
Like Sarclisa IV, Sarclisa subcutaneous is also approved across four indications in the EU, including in combination with bortezomib, lenalidomide, and dexamethasone in both transplant-ineligible newly diagnosed MM (NDMM, TI) and transplant-eligible NDMM (NDMM, TE) as well as in relapsed and/or refractory (R/R) MM, in combination with pomalidomide and dexamethasone (Pd) or with carfilzomib and dexamethasone.
The company noted the approval was based on encouraging results from the pivotal IRAKLIA phase 3 study in relapsed/refractory multiple myeloma, which demonstrated non-inferiority of Sarclisa SC administered as a fixed subcutaneous dose via on-body injector (OBI) compared with weight-based intravenous (IV) Sarclisa, both in combination with pomalidomide and dexamethasone (Pd), in adult patients who had received at least one prior line of therapy.
According to the phase 3 IRAKLIA study, Sarclisa SC in combination with Pd administered using OBI resulted in a 71.1% objective response rate (ORR), compared to 70.5% with Sarclisa IV-Pd. This resulted in establishing non-inferiority in patients with R/R MM who had previously received one line of treatment. In 25% of patients treated with Sarclisa IV-Pd and 1.5% treated with Sarclisa SC-Pd, there were systemic infusion reactions.
Additionally, in the IRAKLIA study, 70% of patients were satisfied with Sarclisa SC administered via an OBI compared to 53.4% of patients receiving Sarclisa IV.
Sarclisa, also known as isatuximab, is an anti-CD38 monoclonal antibody used in the treatment of multiple myeloma (MM) that provides the option for both subcutaneous (SC) administration via the on-body injector (OBI) and manual injection. Additionally, there are ongoing regulatory submissions for the SC formulation of Sarclisa currently under review by authorities in the U.S., China, and Japan.
Sarclisa in conjunction with CirCLIQ on-body injector (OBI), an automated injector, helps to deliver Sarclisa subcutaneously for both outpatient and/or home settings, noted the firm.
Sanofi's fiscal year ended in June 2025 reported a net revenue of €19.88 billion compared to €18.36 billion in the prior year.
Sanofi has traded between $42.28 and $52.68 over the last year.
Sanofi is currently trading at $44.44, down 1.30%
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