FDA Approves Elotuzumab, Second Monoclonal Antibody Treatment for Multiple Myeloma

On November 30, 2015, the US Food and Drug Administration (FDA) approved elotuzumab (Empliciti, Bristol-Myers Squibb) as a second-line treatment for multiple myeloma, in combination with two other agents. The FDA approved use of the “immune-stimulating” monoclonal antibody in combination with lenalidomide (Revlimid, Celgene) and dexamethasone for patients whose myeloma was refractory to previous treatment with one to three medications.

“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 FDA Center for Drug Evaluation and Research’s Office of Hematology and Oncology Products. “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 previously approved daratumumab (Darzalex, Janssen Biotech, Inc.) as a multiple myeloma treatment, Dr. Pazdur noted.

The elotuzumab approval followed findings from a 646-patient, open-label, randomized clinical trial in which the combination therapy was shown to prolong time to relapse and to improve complete or partial tumor response. In that study, the combination therapy of elotuzumab, lenalidomide, and dexamethasone was associated with a longer progression-free survival time (19.4 months) than patients in a control group receiving only lenalidomide and dexamethasone (14.9 months). Partial or complete tumor shrinkage was reported for 78.5% of patients taking the elotuzumab combination therapy, versus 65.5% of patients in the control group, Dr. Pazdur noted.

Elotuzumab was associated with fatigue, diarrhea, pyrexia, constipation, cough, upper respiratory tract infection, pneumonia, peripheral neuropathy, and decreased appetite, the FDA noted in its announcement.

The FDA had granted elotuzumab breakthrough therapy, priority review, and orphan drug designations, hastening the regulatory approval process.