publication date: May. 11, 2018
Drugs and Targets
FDA approves Darzalex for newly diagnosed multiple myeloma patients who are transplant ineligible
FDA has approved Darzalex (daratumumab) in combination with Velcade (bortezomib), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Darzalex is sponsored by Janssen Pharmaceutical Companies, a unit of Johnson & Johnson.
Darzalex is the first monoclonal antibody approved for newly diagnosed patients with this disease. Clinical trial results showed Darzalex in combination with VMP reduced the risk of disease progression or death by 50 percent compared to treatment with VMP alone.
“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,” said Andrzej Jakubowiak, director of the Multiple Myeloma Program at University of Chicago Medical Center, Chicago, Illinois and a Darzalex clinical study investigator. “In clinical studies, patients who received treatment with daratumumab experienced a lower risk of disease progression and higher rates of response.”
The FDA approval of Darzalex in combination with VMP is supported by data from the randomized, open-label, multicenter phase III ALCYONE (MMY3007) study, recently published in the New England Journal of Medicine.
The combination of Darzalex with VMP reduced the risk of disease progression or death by 50 percent, compared to treatment with VMP alone (Hazard Ratio = 0.50; 95 percent CI [0.38-0.65], p<0.0001). The median progression-free survival for Darzalex-VMP had not yet been reached, compared to a median PFS of 18.1 months for patients who received VMP alone.
Treatment with Darzalex in combination with … Continue reading FDA approves Darzalex for newly diagnosed multiple myeloma patients who are transplant ineligible
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