France-based Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving marketing approval in the European Union (EU) for its CD38 monoclonal antibody (mAb) Sarclisa (isatuximab) in combination with the standard-of-care regimen of bortezomib, lenalidomide, and dexamethasone (VRd). The approval is for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). This indication was previously viewed favorably by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in November of last year.
Previous Approvals and Clinical Data
Sarclisa has previously received marketing approvals in the EU for use in combination with pomalidomide and dexamethasone (pom-d) and with carfilzomib and dexamethasone (Kd) for relapsed or refractory multiple myeloma (R/R MM) patients who have received at least one prior treatment. The latest EU approval is based on positive results from the Phase III IMROZ study, which demonstrated significantly improved progression-free survival (PFS) in NDMM patients treated with the Sarclisa/VRd combination compared to VRd alone. The study also confirmed a favorable safety profile for the Sarclisa combination therapy.
Future Outlook
With this approval, Sanofi further solidifies its position in the treatment landscape for multiple myeloma, offering a new option for patients who are ineligible for autologous stem cell transplant. The positive results from the IMROZ study highlight Sarclisa’s potential to improve outcomes for patients with this challenging condition.-Fineline Info & Tech
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