The European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). This decision marks a significant step forward in the treatment landscape for patients with multiple myeloma. A final decision from the EMA is expected in the coming months.
Dietmar Berger, M.D., Ph.D., Chief Medical Officer, Global Head of Development at Sanofi, stated, "The positive CHMP opinion is an important step forward for people with transplant-ineligible newly diagnosed multiple myeloma for whom effective front-line therapy may improve long-term outcomes. If approved, this Sarclisa-based combination could establish a new standard-of-care treatment approach for patients in the EU, helping to address a critical care gap in multiple myeloma treatment, and reinforcing Sarclisa’s potential as the anti-CD38 therapy of choice."
IMROZ Phase 3 Trial
The CHMP's positive opinion is supported by data from the IMROZ phase 3 study, which was presented at the American Society of Clinical Oncology (ASCO) 2024 annual meeting, the European Hematology Association (EHA) 2024 meeting, and published in The New England Journal of Medicine. The IMROZ trial is the first global Phase 3 study evaluating a CD38 monoclonal antibody in combination with standard-of-care VRd. The study demonstrated a statistically significant improvement in progression-free survival (PFS) compared to VRd alone in transplant-ineligible NDMM patients. The safety and tolerability profile of Sarclisa observed in the trial was consistent with the established safety profiles of both Sarclisa and VRd, with no new safety signals identified.
Regulatory Landscape and Prior Approvals
In September 2024, the U.S. Food and Drug Administration (FDA) approved Sarclisa in combination with VRd for the treatment of adult patients with NDMM who are not eligible for ASCT. This approval represented the first global approval for Sarclisa in the first-line setting. The FDA also granted orphan drug exclusivity for Sarclisa for this indication.
Sarclisa is currently approved in more than 50 countries, including the United States and the European Union, for two indications in the treatment of certain adult patients with relapsed or refractory multiple myeloma (MM).
