CHMP recommends EC approval of Isa-VRd for the treatment of transplant-eligible patients with NDMM

On June 23, 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of isatuximab, an anti-CD38 monoclonal antibody, in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. This announcement is based on results from the phase III GMMG-HD7 trial (NCT03617731).¹

GMMG-HD7 trial¹

GMMG-HD7 is an investigational, pivotal, randomized, open-label, multicenter, two-part, phase III trial evaluating the addition of isatuximab to VRd as induction therapy for transplant-eligible NDMM. The study enrolled 662 transplant-eligible patients with NDMM across 67 sites in Germany. 

In Part 1, patients were randomized to receive VRd with or without isatuximab during induction. Post-transplant, Part 2 re-randomized patients to maintenance with lenalidomide ± isatuximab. Primary endpoints included MRD negativity after induction and PFS post-transplant. 

The Multiple Myeloma Hub previously reported on outcomes from Part 1 of the trial. Briefly, isatuximab in combination with VRd significantly improved minimal residual disease (MRD) negativity and prolonged progression-free survival (PFS) compared with VRd alone.