FDA approves Sarclisa as first-line treatment for newly diagnosed multiple myeloma patients unfit for transplant.
The FDA has approved Sarclisa (isatuximab) as a first-line treatment for adults with newly diagnosed multiple myeloma who cannot undergo autologous stem cell transplant. In combination with bortezomib, lenalidomide, and dexamethasone (VRd), Sarclisa reduced the risk of disease progression or death by 40% compared to VRd alone, based on the IMROZ phase 3 study. This marks Sarclisa's third indication in the U.S. and its first for newly diagnosed patients.
September 20, 2024
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