New research suggested the monoclonal antibody may help ward off progression to myeloma or death.
SAN DIEGO — The multiple myeloma drug daratumumab , an anti-CD38 monoclonal antibody , dramatically reduced progression to active MM or death in patients with high-risk smoldering MM , a landmark randomized, open-label, phase 3 study found.
At 5 years, progression-free survival — the primary endpoint — was 63.1% and 40.8% . Researchers estimated 60-month PFS rates at 63.1% and 40.8%, respectively, and overall response rates were 63.4% vs 2.0% with 15 deaths in the daratumumab and 26 in the active monitoring group. Grade 3/4 treatment-emergent adverse events occurred in 40.4% and 30.1% of patients. The most common was hypertension .
For now, Banerjee said, clinicians should wait for the US Food and Drug Administration approval before prescribing daratumumab for high-risk SMM.
Myeloma Plasma Cell Myeloma Biologic Therapy Biologics Immunomodulator Lenalidomide Monoclonal Antibody Cetuximab Rituximab Bone Marrow Medulla Ossea Adverse Effects Side Effects Bones U.S. Food And Drug Administration United States Food And Drug Administration FDA Food And Drug Administration (FDA) Food And Drug Administration Patient Safety Practice Management
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