Sanofi’s Sarclisa gains third FDA approval

The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT).

Marketed by French pharma major Sanofi (Euronext: SAN), Sarclisa is the first anti-CD38 therapy in combination with standard-of-care VRd to significantly reduce disease progression or death (by 40%) compared to VRd alone for patients with NDMM not eligible for transplant. This decision marks the third approved indication for Sarclisa in the USA and the first authorized indication in newly diagnosed patients.

Sarclisa will compete with US healthcare giant Johnson & Johnson’s (NYSE: JNJ) Darzalex (daratumumab) in this indication, though that could be tough, given the head-start for the J&J drug which notched up sales of $9.7 billion last year. For its part, Sarclisa sales were only $381 million in 2023.