The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of transplant-ineligible newly diagnosed multiple myeloma (NDMM) patients. This acceptance for Priority Review underscores the potential of Sarclisa as a groundbreaking therapy. If approved, it would mark the first anti-CD38 therapy in conjunction with standard-of-care VRd for newly diagnosed patients not eligible for transplant, constituting the third indication for Sarclisa in multiple myeloma.
The sBLA submission is supported by positive outcomes from the IMROZ phase 3 clinical trial. This study demonstrated a statistically significant enhancement in progression-free survival (PFS) with Sarclisa in combination with VRd compared to VRd alone in transplant-ineligible NDMM patients. Importantly, the safety profile observed in the trial was consistent with known data for Sarclisa and VRd.
The IMROZ trial enrolled 446 patients across 21 countries, assessing Sarclisa’s efficacy in combination with VRd. Sarclisa was administered intravenously at a dose of 10 mg/kg weekly for five weeks during the first cycle and every two weeks thereafter in conjunction with bortezomib, lenalidomide, and dexamethasone. The primary endpoint of the trial was progression-free survival, with key secondary endpoints including complete response rate, minimal residual disease (MRD) negativity rate, and overall survival.
Sarclisa, a monoclonal antibody targeting CD38, has already garnered approvals in various countries for its use in relapsed refractory multiple myeloma (RRMM) in combination with pomalidomide and dexamethasone, as well as with carfilzomib and dexamethasone. Ongoing phase 3 trials continue to assess Sarclisa in combination with standard treatments across the multiple myeloma treatment continuum, with investigations also exploring its potential in other hematologic malignancies.
Sanofi, the pharmaceutical company behind Sarclisa, emphasizes its commitment to innovation and improving patient outcomes. Through the pursuit of scientific breakthroughs, Sanofi aims to address unmet medical needs and transform the landscape of healthcare.