Sarclisa Gains FDA Approval as First-Line Treatment for Newly Diagnosed Multiple Myeloma

Approval Date:
The FDA approved Sarclisa (isatuximab) on September 20, 2024, for use in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT).

Clinical Significance:
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.

Study Basis:
The approval is based on positive results from the IMROZ phase 3 study, which demonstrated statistically significant improvement in progression-free survival (PFS) with Sarclisa in combination with VRd compared to VRd alone in transplant-ineligible patients with NDMM.

Third Indication:
This marks the third approved indication for Sarclisa in the US, expanding its use beyond previously treated multiple myeloma to include newly diagnosed patients.

Priority Review:
The FDA evaluated Sarclisa for this indication under Priority Review, reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.

Global Availability:
Sarclisa is also approved in more than 50 countries across two indications for the treatment of people with relapsed or refractory disease.