Sanofi's Sarclisa Granted FDA Priority Review For Transplant-Ineligible Multiple Myeloma Treatment

(RTTNews) - Sanofi - Aventis Groupe said that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of Sarclisa or isatuximab in combination with bortezomib, lenalidomide and dexamethasone (VRd) for the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma.

If approved, Sarclisa would be the first anti-CD38 therapy in combination with standard-of-care VRd in newly diagnosed patients not eligible for transplant, which would be the third indication for Sarclisa in multiple myeloma.

The target action date for the FDA decision is September 27, 2024.

A regulatory submission is also under review in the European Union.

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