Darzalex subcutaneous regimen approved by European Commission

New treatment option for patients with newly diagnosed multiple myeloma

The European Commission has approved the subcutaneous (SC) formulation of DARZALEX (daratumumab) in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT).

This approval allows patients to receive this quadruplet therapy at initial diagnosis, providing a new treatment that has shown significant improvements in outcomes.

The approval is based on data from the phase 3 PERSEUS study. This study evaluated the daratumumab SC-based quadruplet regimen for induction and consolidation therapy, followed by daratumumab SC and lenalidomide (D-R) maintenance therapy. It compared this with the traditional regimen of bortezomib, lenalidomide, and dexamethasone (VRd) during induction and consolidation, followed by lenalidomide (R) maintenance in 709 patients with NDMM eligible for ASCT.

“Multiple myeloma is a complex and highly varied disease, which reinforces the need for continuous innovation in first-line treatment strategies to deepen responses, reduce relapse and ultimately improve long-term outcomes,” said Dr Paula Rodriguez-Otero from the Department of Hematology at Cancer Center Clínica Universidad de Navarra.

“The EC approval of this daratumumab SC-based quadruplet regimen offers a practice-changing new option, that has shown the potential to significantly improve progression-free survival, complete response rates, and MRD-negativity status compared to the current standard of care,” she added.

The phase 3 PERSEUS study results showed a 58 percent reduction in the risk of disease progression or death for patients treated with the new regimen.

This new approval reinforces daratumumab SC as a foundational element for optimizing frontline treatment of patients with newly diagnosed multiple myeloma, significantly delaying disease progression.