CHMP Recommends EU Approval of Sarclisa for Newly Diagnosed Multiple Myeloma Patients Ineligible for Transplant

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a favorable opinion recommending the approval of Sarclisa, in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for treating adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). This decision follows a successful phase 3 clinical trial (IMROZ study) that demonstrated the significant efficacy of Sarclisa when combined with VRd, compared to VRd alone, in improving progression-free survival (PFS) for these patients.

Dr. Dietmar Berger, the Chief Medical Officer and Global Head of Development at Sanofi, highlighted the significance of this positive CHMP opinion, emphasizing that it represents a crucial advancement for patients with newly diagnosed multiple myeloma who cannot undergo transplants. He expressed optimism that, upon approval, the Sarclisa-based combination could set a new standard of care for these patients in Europe, addressing a vital treatment gap and reinforcing Sarclisa’s potential as the anti-CD38 therapy of choice.

In September 2024, the US Food and Drug Administration (FDA) had already approved Sarclisa in combination with VRd for treating NDMM patients ineligible for ASCT. This approval marked the first global endorsement of Sarclisa in the first-line setting, along with the FDA granting orphan drug exclusivity for Sarclisa in this indication.

Sarclisa is already approved for various indications in over 50 countries, including the US and EU, particularly for treating certain adult patients with relapsed or refractory multiple myeloma (RRMM). The IMROZ phase 3 study, which underpinned the CHMP’s positive opinion, is noteworthy as the first global phase 3 study to show that combining an anti-CD38 therapy with VRd significantly improves PFS in transplant-ineligible NDMM patients compared to VRd alone. The safety and tolerability profile of Sarclisa observed in this study was consistent with its established profile, with no new safety concerns.

Sarclisa (isatuximab) is a monoclonal antibody targeting the CD38 receptor on multiple myeloma cells, designed to induce tumor cell death and activate the immune system. The non-proprietary name for Sarclisa in the US is isatuximab-irfc, following the FDA's nonproprietary naming guidance for biological products.

Currently, Sarclisa is approved in over 50 countries for two indications: in combination with pomalidomide and dexamethasone for treating RRMM patients who have received at least two prior therapies, and in combination with carfilzomib and dexamethasone for treating RRMM patients who have received one to three prior lines of therapy. In the US, Sarclisa is also approved in combination with VRd as a first-line treatment for NDMM patients ineligible for ASCT.

Sanofi is committed to further advancing Sarclisa through a comprehensive clinical development program, including several phase 2 and phase 3 studies spanning six potential indications in multiple myeloma treatment. Additionally, the company is exploring a subcutaneous administration method for Sarclisa in clinical trials. The safety and efficacy of Sarclisa for indications and delivery methods outside its approved uses have not been evaluated by any regulatory authority.

Sanofi is dedicated to becoming a leading global immunoscience company, focusing on difficult-to-treat cancers, including multiple myeloma and other hematologic malignancies. By prioritizing its pipeline and leveraging its expertise in immunoscience, Sanofi aims to drive innovation and improve outcomes for patients with critical unmet needs.