PARIS (dpa-AFX) - The European Commission has approved Sarclisa (isatuximab) subcutaneous (SC) in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications for Sarclisa intravenous (IV) formulation, Sanofi SA (SNY) said in a statement on Monday.
Sarclisa is the first anticancer therapy in the EU to be administered through an on-body injector (OBI) and manual SC administration and can provide the flexibility of administration at patients' homes and in the outpatient setting.
Since launching in 2020, Sarclisa has been prescribed to patients worldwide. Sarclisa IV is currently 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). In relapsed and/or refractory (R/R) MM, Sarclisa is approved in combination with pomalidomide and dexamethasone (Pd) or with carfilzomib and dexamethasone.
SNY closed at $45.02 on June 5, up $0.64 or 1.44%. In overnight trading on June 7, the stock slipped slightly to $44.75, down $0.27 or 0.60%.
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