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FDA approves Empliciti for multiple myeloma
The FDA today approved elotuzumab in combination with two other therapies for treatment of patients with multiple myeloma who received one to three prior therapies.
Elotuzumab (Empliciti, Bristol-Myers Squibb) — which activates the body’s immune system to attack and kill multiple myeloma cells — is indicated for use in combination with lenalidomide (Revlimid, Celgene) and dexamethasone.
Richard Pazdur
“We are continuing to learn about the ways the immune system interacts with different types of cancer, including multiple myeloma,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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 based its approval in part on safety and efficacy data from an open-label, randomized study that included 646 patients with myeloma who either did not respond to or relapsed after prior treatment.
Researchers assigned patients to lenalidomide plus dexamethasone with or without elotuzumab.
Patients assigned elotuzumab experienced longer median PFS (19.4 months vs. 14.9 months). Researchers also reported a higher rate of complete or partial tumor shrinkage in the elotuzumab group (78.5% vs. 65.5%).
The most common adverse events associated with elotuzumab included fatigue, peripheral neuropathy, pneumonia and constipation.