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FDA Approves Elotuzumab for Multiple Myeloma

Dr. Richard Pazdur

Richard Pazdur, MD

The FDA approved elotuzumab (Empliciti) for use in combination with lenalidomide (Revlimid) and dexamethasone for patients with multiple myeloma following the failure of 1 to 3 prior therapies.

The approval was based on data from the phase III ELOQUENT-2 trial, in which the 3-drug elotuzumab combination reduced the risk of disease progression by 30% compared with lenalidomide/dexamethasone alone.

''We are continuing to learn about the ways the immune system interacts with different types of cancer, including multiple myeloma," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. ''Today's approval is the second monoclonal antibody approved to treat patients with multiple myeloma and works with another approved therapy to provide additional benefit.”

The FDA approved the monoclonal antibody daratumumab (Darzalex) for multiple myeloma earlier this month. Click here to read the full article at

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