Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sarclisa in combination with VRd for the treatment of transplant-eligible newly diagnosed multiple myeloma (NDMM) patients, indicating significant progress in addressing unmet patient needs in this area [1][2]. Group 1: Study and Approval Details - The positive CHMP opinion is based on results from the GMMG-HD7 study, which demonstrated a deep and rapid response in transplant-eligible NDMM patients using an anti-CD38-based induction regimen [2][3]. - GMMG-HD7 is the first phase 3 study to show a higher proportion of patients achieving minimal residual disease (MRD) negativity and significant progression-free survival (PFS) benefits post-induction [3][4]. - The study enrolled 662 patients across 67 sites in Germany, with participants receiving three 42-day cycles of VRd, and Sarclisa added to one arm of the study [6][7]. Group 2: Clinical Evidence and Outcomes - The results indicated the highest post-induction and post-transplant MRD negativity rates for any CD38 monoclonal antibody using VRd as a backbone in transplant-eligible NDMM [4][8]. - The primary endpoints of the study included MRD negativity following induction therapy and PFS after post-transplant randomization, with the latter expected to be available later [8][9]. - Secondary endpoints included rates of complete response after induction, overall survival, and safety, with MRD negativity assessed by next-generation flow cytometry [9]. Group 3: Current Approvals and Future Potential - Sarclisa is currently approved in the EU for three indications across different lines of therapy for adult patients with relapsed and/or refractory multiple myeloma and NDMM who are not eligible for transplant [5][10]. - If approved, the new regimen would represent the fourth indication in the EU and the second in the front-line setting globally, enhancing treatment options for transplant-eligible patients [8][10].