FDA approves Sanofi's Sarclisa for first-line treatment of newly diagnosed multiple myeloma.

The FDA has approved Sanofi's Sarclisa (siltuximab) with bortezomib, lenalidomide, and dexamethasone as a first-line treatment for adults with newly diagnosed multiple myeloma not eligible for stem cell transplant. This is Sarclisa's third approval in the US and its first for newly diagnosed patients. The approval, based on the IMROZ phase 3 study, demonstrated a 40% reduction in disease progression compared to standard treatment.

September 23, 2024
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