DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible
- The European Commission has approved the subcutaneous daratumumab-based quadruplet regimen for newly diagnosed multiple myeloma patients eligible for transplant, marking a significant advancement in their treatment options.
- The Phase 3 PERSEUS study supports this approval, demonstrating the regimen's improved progression-free survival rates and favorable safety profile, making treatment more effective and accessible.
- This new regimen enhances convenience with a subcutaneous administration, reducing hospital visits, and aims to provide a comprehensive, long-term management approach for multiple myeloma, improving patient outcomes.
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A New Era in Cancer Therapy: DARZALEX® (Daratumumab)-SC Quadruplet Regimen Receives EU Approval
In a groundbreaking move, the European Commission has approved the DARZALEX® (daratumumab) subcutaneous (SC) formulation-based quadruplet regimen for the treatment of newly diagnosed multiple myeloma patients who are transplant-eligible. This significant development marks a pivotal step forward in the fight against multiple myeloma, a complex and often debilitating blood cancer.
What is Multiple Myeloma?
Multiple myeloma is a type of blood cancer characterized by the proliferation of malignant plasma cells in the bone marrow. This cancer can lead to issues like bone erosion, anemia, and kidney damage. Traditional treatments often include chemotherapy, stem cell transplants, and targeted therapies. However, for patients who are not candidates for stem cell transplants, treatment options have been limited, leading to a pressing need for innovative therapies.
The DARZALEX® (Daratumumab) Revolution
DARZALEX® (daratumumab) is a monoclonal antibody that targets the CD38 receptor on plasma cells, marking them for destruction. Originally approved in 2016, daratumumab has been a game-changer in treating multiple myeloma. The subcutaneous formulation of daratumumab offers a more convenient dosing regimen compared to its intravenous counterpart, requiring less hospital time and making it more accessible to patients.
The Phase 3 PERSEUS Study: A Key Milestone
The approval is supported by data from the Phase 3 PERSEUS study, which evaluated the efficacy and safety of daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd). This study enrolled 709 patients with newly diagnosed multiple myeloma who were eligible for autologous stem cell transplantation (ASCT).
Key findings from the PERSEUS study:
- Progression-Free Survival (PFS): The estimated 48-month PFS rate was 84.3% with daratumumab plus VRd induction and consolidation therapy followed by maintenance lenalidomide (D-VRd).
- Minimal Residual Disease (MRD): The regimen significantly improved MRD-negativity rates.
- Safety Profile: The overall safety profile of daratumumab-VRd was consistent with the known safety profiles for daratumumab SC and VRd. Common haematologic adverse reactions included neutropenia, thrombocytopenia, and anaemia. Non-haematologic adverse reactions included peripheral neuropathy and fatigue.
Why is This New Regimen Important?
The approval of this daratumumab SC-based quadruplet regimen offers several significant benefits to patients:
- Improved Outcomes: By incorporating daratumumab SC into the treatment regimen, patients can achieve better minimal residual disease (MRD) negativity rates, which is a critical indicator of treatment success.
- Enhanced Convenience: The subcutaneous formulation reduces the need for frequent hospital visits, making it easier for patients to adhere to their treatment plans.
- Better Long-term Management: This regimen provides a more comprehensive approach to managing multiple myeloma from induction through to maintenance, ensuring that patients receive continuous care.
What Do Experts Say?
Edmond Chan, MBChB, M.D. (Res), Senior Director, EMEA Therapeutic Area Lead Haematology, Innovative Medicine at Johnson & Johnson, stated, “The European Commission’s approval of this daratumumab quadruplet regimen marks a pivotal step forward in the treatment of newly diagnosed multiple myeloma... By incorporating daratumumab SC into this regimen, we are further optimizing frontline therapy for patients, building on our aim to transform outcomes and establish new standards of care for eligible patients from induction through to maintenance.”
Dr. Paula Rodriguez-Otero, Department of Hematology, Cancer Center Clínica Universidad de Navarra, Pamplona, Navarra, Spain, added, “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. 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.”
What's Next?
For patients with newly diagnosed multiple myeloma who are transplant-eligible, this new regimen offers a promising avenue for improved treatment outcomes. The European Commission's approval signifies a significant shift towards more effective and accessible therapies, aligning with the broader goal of enhancing patient care and quality of life.
Conclusion
The approval of the DARZALEX® (daratumumab) SC-based quadruplet regimen for patients with newly diagnosed multiple myeloma marks a significant milestone in the fight against this disease. This innovative therapy combines the strengths of daratumumab with established treatments like bortezomib, lenalidomide, and dexamethasone to provide better outcomes and greater convenience for patients. As researchers continue to explore new avenues in cancer treatment, this development serves as a testament to the power of collaboration and innovation in healthcare.
References
- https://innovativemedicine.jnj.com/emea/johnson-johnson-submits-application-to-the-european-medicines-agency-for-darzalex-daratumumab-sc-based-quadruplet-regimen-for-newly-diagnosed-multiple-myeloma-patients
- https://www.globenewswire.com/news-release/2024/10/23/2967491/0/en/DARZALEX-daratumumab-SC-based-quadruplet-regimen-approved-by-the-European-Commission-for-patients-with-newly-diagnosed-multiple-myeloma-who-are-transplant-eligible.html
- https://www.medthority.com/news/2024/9/darzalex-daratumumab-based-quadruplet-regimen-receives-positive-chmp-opinion-for-transplant-eligible-patients-with-newly-diagnosed-multiple-myeloma.--johnson--johnson
- https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex
- https://www.onclive.com/view/subcutaneous-daratumumab-quadruplet-approaches-eu-approval-for-newly-diagnosed-myeloma
