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.
May 27, 2024
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