Fri Sep 20 11:40:00 UTC 2024: ## New Subcutaneous Daratumumab Regimen Recommended for Frontline Multiple Myeloma Treatment
**BEERSE, BELGIUM** – September 20, 2024 – Janssen Cilag International NV announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a new subcutaneous (SC) formulation of DARZALEX® (daratumumab) for treating newly diagnosed multiple myeloma patients eligible for autologous stem-cell transplant (ASCT).
This recommendation is based on the positive results of the Phase 3 PERSEUS study, which demonstrated a 60% reduction in the risk of disease progression or death with the daratumumab SC quadruplet regimen (D-VRd) compared to the standard-of-care triplet regimen (VRd).
The CHMP recommendation highlights the potential of this new regimen to establish a new standard of care for eligible patients by improving progression-free survival and transforming the treatment landscape.
“Optimising frontline therapy is crucial in disease control and improving long-term outcomes for patients with newly diagnosed multiple myeloma,” said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Haematology, Johnson & Johnson Innovative Medicine. “By incorporating daratumumab SC into this novel quadruplet regimen, we aim to enhance progression-free survival.”
Daratumumab, a CD38-directed antibody, has been a foundational therapy for multiple myeloma since its initial approval in 2016. This recommendation follows the recent US Food and Drug Administration (FDA) approval of daratumumab SC in combination with D-VRd for induction and consolidation in patients with newly diagnosed multiple myeloma.
Multiple myeloma is an incurable blood cancer that affects plasma cells in the bone marrow. This news offers hope for patients, as the new regimen could significantly improve their treatment outcomes.
First Piper 