Sanofi's Sarclisa receives FDA priority review for transplant-ineligible newly diagnosed multiple myeloma treatment.

Sanofi's Sarclisa (isatuximab) granted FDA priority review for transplant-ineligible newly diagnosed multiple myeloma treatment, if approved, would be the first anti-CD38 therapy with standard-of-care VRd in newly diagnosed patients not eligible for transplant. Sarclisa already has two indications in multiple myeloma, with a target action date of September 27, 2024. A regulatory submission is also under review in the EU.