Sanofi secures first CD38 approval for multiple myeloma

The FDA has granted approval for Sarclisa (isatuximab) to be used as part of an initial treatment plan for adults newly diagnosed with multiple myeloma who are not candidates for autologous stem cell transplant. This approval is significant as it introduces the first anti-CD38 therapy combined with bortezomib, lenalidomide, and dexamethasone (VRd) for this particular group of patients.

The decision is based on findings from the IMROZ phase 3 clinical trial, which showed that the addition of Sarclisa to the VRd regimen notably enhanced progression-free survival (PFS). Patients receiving Sarclisa in combination with VRd experienced a 40% reduction in the risk of disease progression or death compared to those who were treated with the VRd regimen alone.

This latest approval is the third for Sarclisa in the United States and the first for newly diagnosed multiple myeloma patients. The FDA granted this approval under Priority Review, indicating the treatment's potential to offer significant improvements over existing options.

Sarclisa is now approved in more than 50 countries worldwide. Sanofi, the pharmaceutical company behind Sarclisa, is continuing to develop the therapy further. The company is actively conducting clinical trials to investigate new combinations and methods of administration to expand the medication's use in treating multiple myeloma.

Initially, the FDA approved Sarclisa in 2020 for use in combination with pomalidomide and dexamethasone. This approval was aimed at treating adults with relapsed refractory multiple myeloma who had already undergone at least two previous therapies.