Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for transplant

Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for transplant
        

• Approval based on positive results from the IMROZ phase 3 study demonstrating Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) significantly improved progression-free survival (PFS), compared to standard-of-care in newly diagnosed adult patients not eligible for autologous stem cell transplant (ASCT)
• Third indication for Sarclisa, evaluated under FDA Priority Review, underscores Sanofi’s commitment to helping close a critical care gap in multiple myeloma (MM)

PARIS, September 21, 2024. 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). 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.

Thomas Martin M.D.
Helen Diller Family Comprehensive Cancer Center Clinical Professor of Medicine at the University of California San Francisco
“Multiple myeloma is most frequently diagnosed in patients 65 years and older, yet the options for treatment in this population are limited due to a combination of age, frailty, and co-morbidities. This has resulted in a longstanding need for new treatment options that can potentially improve the standard-of-care. The significant clinical benefit and improvements in progression-free survival demonstrated by the IMROZ regimen of isatuximab plus VRd versus VRd alone make today’s approval an important moment for this vulnerable patient population and the larger multiple myeloma community.”

This decision marks the third approved indication for Sarclisa in the US and the first approved indication in newly diagnosed patients. The FDA evaluated Sarclisa for this indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. Sarclisa is also currently approved in more than 50 countries across two indications for the treatment of people with relapsed or refractory disease.