17 May DARZALEX® (daratumumab) Approved for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible
MedicalResearch.com Interview with:
Dr. Jakubowiak
Andrzej Jakubowiak, MD, PhD
Professor of Medicine
Director, Myeloma Program
University of Chicago
MedicalResearch.com: What is the background for this announcement? Would you briefly explain what is meant by multiple myeloma?
Response: DARZALEX (daratumumab) in combination with VELCADE (bortezomib), melphalan and prednisone – VMP – received U.S. FDA approval for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). With this most recent approval, DARZALEX is now the first monoclonal antibody approved for newly diagnosed patients with this disease.
Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow. Despite the introduction of new medicines over the last decade, which has led to significant improvements in outcomes for patients with multiple myeloma, multiple myeloma remains an incurable disease. In 2018, it is estimated that 30,700 people will be diagnosed and 12,770 will die from the disease in the United States.
MedicalResearch.com: : How does daratumumab differ from traditional chemotherapy?
Response Daratumumab is a fully human monoclonal antibody which binds CD38, a surface protein that is highly expressed on multiple myeloma cells, regardless of disease stage. DARZALEX is the first CD38-directed antibody approved anywhere in the world.
MedicalResearch.com: What are the main results of the Phase 3 ALCYONE (MMY3007) study?
Response: According to results of the Phase 3 ALYCONE (MMY3007) study supporting this approval, DARZALEX in combination with VMP reduced the risk of disease progression or death by 50 percent, compared to VMP alone. Treatment with DARZALEX in combination with VMP also significantly improved overall response rates compared to VMP alone.
MedicalResearch.com: For whom is the combination of daratumumab with VMP recommended?
Response: DARZALEX (daratumumab) in combination with VMP is indicated for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
MedicalResearch.com: Is there anything else you would like to add?
Response: This approval is significant as we now have the first antibody-based regimen for treating newly diagnosed multiple myeloma patients who are not eligible for a stem cell transplant.
Selecting the right regiment is critical for newly diagnosed patients, who are more likely to benefit from therapy. In clinical studies, patients who received treatment with daratumumab experienced a lower risk of disease progression and higher rates of response. Significantly, patients receiving DARZALEX in combination with VMP achieved a more than three-fold increase in the minimal residual disease (MRD) negativity rate.
My disclosures are: Consulting and on Advisory Boards for ABBVIE, Amgen, BMS, Celgene, Janssen, Karyopharm, Takeda, SkylineDx
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Last Updated on May 17, 2018 by Marie Benz MD FAAD