Bristol-Myers Squibb and AbbVie announced that FDA has approved Empliciti (elotuzumab) for the treatment of multiple myeloma as combination therapy with lenalidomide and dexamethasone in patients who have received one to three prior therapies. Empliciti is an immunostimulatory antibody that specifically targets signaling lymphocyte activation molecule family member 7 (SLAMF7), a cell-surface glycoprotein.

Dosage and Administration: With lenalidomide and dexamethasone: 10 mg/kg administered intravenously every week for the first two cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity. Premedicate with dexamethasone, diphenhydramine, ranitidine and acetaminophen.

Adverse Reactions: Infusion reactions were reported in approximately 10% of patients treated with Empliciti with lenalidomide and dexamethasone. All reports of infusion reaction were Grade 3 or lower. Grade 3 infusion reactions occurred in 1% of patients. The most common adverse reactions in clinical trials were fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, and pneumonia.

Citation: Bristol-Myers Squibb and AbbVie receive FDA approval of Empliciti (elotuzumab) for the treatment of patients with multiple myeloma who have received one to three prior therapies. [news release]. Princeton, NJ: Bristol-Myers Squibb; November 30, 2015. http://news.bms.com/press-release/bristol-myers-squibb-and-abbvie-receive-fda-approval-empliciti-elotuzumab-treatment-pa&t=635845558569079361. Accessed November 30, 2015.