European CHMP Recommends Sarclisa (isatuximab-irfc) for Approval to Treat Transplant-Eligible Newly Diagnosed Multiple Myeloma 

June 23, 2025—According to a press release from Sanofi, "The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa® in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. A final decision is expected in the coming months."

About the CHMP Opinion and Study Findings

• A positive opinion from the Committee for Medicinal Products for Human Use (CHMP) was based on results from the GMMG-HD7 study, a Phase 3 clinical trial in newly diagnosed, transplant-eligible multiple myeloma (NDMM) patients.
• The GMMG-HD7 study is the first Phase 3 trial to show that adding Sarclisa (isatuximab) to Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone [or, VRd] before transplant improves both:
  • Minimal residual disease (MRD) negativity after induction therapy
  • Progression-free survival (PFS) from the time of first randomization
• These benefits were seen regardless of post-transplant maintenance therapy and without consolidation therapy.

Study Highlights

• Enrolled 662 transplant-eligible NDMM patients across 67 German sites.
• Two-part design:
  • Part 1 (Induction): Compared VRd with or without Sarclisa before transplant.
  • Part 2 (Maintenance): Re-randomized post-transplant to receive Sarclisa + lenalidomide or lenalidomide alone.
• Primary endpoint (Part 1): MRD negativity after induction was met.
• Secondary endpoints: PFS, complete response rates, overall survival, safety.
• Sarclisa demonstrated the highest MRD negativity rates seen to date in a VRd-based regimen for transplant-eligible NDMM.

About Sarclisa (isatuximab)

• Sarclisa® is an anti-CD38 monoclonal antibody approved in over 50 countries.
• It is used in relapsed/refractory multiple myeloma (R/R MM) and now, increasingly, in newly diagnosed multiple myeloma (NDMM):
  • In the EU, US, and China: Approved in combination with VRd for transplant-ineligible NDMM (based on IMROZ study).
  • In Japan: Approved for front-line use regardless of transplant eligibility.
• GMMG-HD7 adds to the growing body of evidence supporting Sarclisa’s use early in the treatment course for transplant-eligible patients.

Read the full Sanofi press release from the button below to learn more.