Sanofi’s Sarclisa moves closer to third myeloma approval

The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Sarclisa (isatuximab) alongside bortezomib, lenalidomide and dexamethasone (VRd) for transplant-ineligible newly diagnosed multiple myeloma (NDMM).

If approved, Sanofi's (Euronext: SAN) 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.

"Transplant-ineligible patients who can face poor outcomes from the disease"The target action date for the FDA decision is September 27 this year. A regulatory submission is also under review in the European Union (EU).