The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued 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, based on the pivotal IMROZ phase 3 study, marks a significant step forward in the treatment landscape for these patients. A final decision from the EMA is anticipated in the coming months.
IMROZ Study: A New Standard of Care?
The CHMP's positive opinion is rooted in the data from the IMROZ phase 3 study, a global trial evaluating Sarclisa in combination with the standard-of-care VRd regimen. The study demonstrated a statistically significant improvement in progression-free survival (PFS) for patients receiving the Sarclisa combination compared to those treated with VRd alone. The safety and tolerability profile of Sarclisa in the study was consistent with previous findings, with no new safety signals identified.
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."
The IMROZ study results were presented at the American Society of Clinical Oncology (ASCO) and the European Hematology Association (EHA) annual meetings in 2024, and published in The New England Journal of Medicine.
Sarclisa: Targeting CD38 in Multiple Myeloma
Sarclisa (isatuximab) is a monoclonal antibody that targets the CD38 receptor, which is highly expressed on multiple myeloma cells. By binding to CD38, Sarclisa induces antitumor activity through multiple mechanisms, including programmed tumor cell death (apoptosis) and immunomodulatory activity.
Global Approvals and Ongoing Development
Sarclisa is currently approved in more than 50 countries, including the US and EU, for the treatment of certain adult patients with relapsed or refractory multiple myeloma (RRMM). In September 2024, the US Food and Drug Administration (FDA) approved Sarclisa in combination with VRd for transplant-ineligible NDMM patients, representing the first global approval for Sarclisa in the first-line setting. Sanofi is continuing to investigate Sarclisa in various phase 2 and phase 3 studies across the multiple myeloma treatment continuum, including exploring subcutaneous administration.
