Sanofi: new indication for Sarclisa in US

(CercleFinance.com) - Sanofi announces that the US FDA has approved its Sarclisa, in combination with conventional therapy, for the first-line treatment of adults with newly diagnosed multiple myeloma who are not eligible for transplantation.


This approval is based on the IMROZ Phase III study, which demonstrated that the product, in combination with bortezomib, lenalidomide and dexamethasone, significantly improved progression-free survival compared to reference therapy.

This decision brings the number of approved indications for Sarclisa in the US to three, and represents the first approved indication for newly diagnosed patients. The FDA has granted priority review in this indication.


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