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FDA Approves Daratumumab for Pretreated Multiple Myeloma

Silas Inman @silasinman
Published: Monday, Nov 16, 2015

Dr. Richard Pazdur

Richard Pazdur, MD

Acting 4 months ahead of schedule, the FDA has granted an accelerated approval to the CD38-targeted monoclonal antibody daratumumab (Darzalex) as a monotherapy for patients with multiple myeloma following at least 3 prior therapies, based on data from two open-label clinical trials.

“The responses we saw in clinical trials that led to today’s approval were striking, especially considering that these patients received a median of five prior lines of therapy,” Sagar Lonial, MD, chief medical officer, Winship Cancer Institute of Emory University and Professor and Executive Vice Chair, Department of Hematology and Medical Oncology, Emory University School of Medicine, said in a statement. “It appears the mechanism of action for daratumumab may play an important role in its single-agent activity among this group of advanced-stage multiple myeloma patients.”


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