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Sanofi: approval in multiple myeloma in EU

(CercleFinance.com) - Sanofi reports that the European Commission has approved its Sarclisa in combination with the VRd reference regimen, for the treatment of newly diagnosed multiple myeloma (MMND) in adults ineligible for autologous stem cell transplantation.


With this extension of marketing authorization, Sarclisa becomes the first anti-CD38, in combination with the VRd regimen (bortezomib, lenalidomide and dexamethasone), approved for this patient population in the European Union.

This approval is based on the results of the IMROZ phase III study, which demonstrated that Sarclisa, in combination with the reference treatment, significantly improved progression-free survival, compared with the reference treatment alone.


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