Sarclisa Receives EU Approval as First Anti-CD38 Therapy for Newly Diagnosed Multiple Myeloma Patients Ineligible for Transplant

Sanofi announced that Sarclisa (isatuximab) has been approved by the European Union (EU) for use in combination with the standard-of-care regimen bortezomib, lenalidomide, and dexamethasone (VRd) to treat adults with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT). This milestone marks Sarclisa as the first anti-CD38 therapy approved in this combination for this patient group in the EU.

Groundbreaking IMROZ Phase 3 Study Findings

The approval is based on results from the IMROZ phase 3 clinical trial, which demonstrated that adding Sarclisa to the VRd regimen significantly improved progression-free survival (PFS) compared to VRd alone. This is Sarclisa's third indication in the EU, including its use in relapsed or refractory multiple myeloma (R/R MM) and now in newly diagnosed patients.

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Regulatory Milestones Across the Globe

In September 2024, the U.S. Food and Drug Administration (FDA) also approved Sarclisa in combination with VRd for transplant-ineligible NDMM patients, granting orphan drug exclusivity for this indication.

Regulatory reviews for this therapy are ongoing in key markets, including Japan and China, reinforcing its growing global presence.

Sarclisa is a monoclonal antibody targeting CD38, a protein abundantly expressed on multiple myeloma cells. By binding to this receptor, the therapy induces tumor cell death through programmed apoptosis and modulates immune activity.

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Sarclisa is currently approved in over 50 countries, including the U.S. and EU, for various indications:

• Relapsed or Refractory Multiple Myeloma (R/R MM): Approved in combination with pomalidomide and dexamethasone (Pd) for patients who have received at least two prior treatments, including lenalidomide and a proteasome inhibitor.

• Relapsed or Refractory MM: Approved with carfilzomib and dexamethasone for patients with 1–3 prior lines of therapy in the U.S. and for patients with at least one prior therapy in the EU.

• Newly Diagnosed MM (NDMM): Now approved with VRd for patients ineligible for ASCT.

Sanofi stated that it is committed to broadening Sarclisa's clinical applications through an extensive development program involving several phase 2 and phase 3 trials. These studies span six potential indications, with ongoing efforts to introduce a subcutaneous delivery option for improved patient convenience.