Following the approval of daratumumab earlier this month
, multiple myeloma patients now have another opportunity to combat the disease: elotuzumab. Marketed as Empliciti, the FDA has granted approval
to elotuzumab in combination with lenalidomide and dexamethasone in patients previously treated with 1 to 3 prior medications. Today’s approval is just 2 months after the monoclonal antibody was accepted for priority review by the FDA.
“We are continuing to learn about the ways the immune system interacts with different types of cancer, including multiple myeloma," said Richard Pazdur, MD, who leads 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 data submitted for review included results from the ongoing ELOQUENT-2 trial, a phase 3 open-label, multicenter global study that included 646 patients at 168 sites who were randomized to receive elotuzumab in combination with lenalidomide and dexamethasone (elotuzumab group) or lenalidomide and dexamethasone alone (control group) in 28-day cycles until disease progression, unacceptable toxicity, or withdrawal of consent. Primary end points of the trial, results of which were published in the New England Journal of Medicine
, were progression-free survival (PFS) and overall response rate (ORR). Secondary end points were overall survival (OS) and severity of pain or interference with daily life.
At a median follow-up of 24.5 months, 35% of patients in the elotuzumab group and 20% in the control group were receiving study treatment. PFS at 1 year was 68% (95% confidence interval [CI], 63 to 73) in the elotuzumab group and 57% (95% CI, 51 to 62) in the control group. Median PFS in the elotuzumab group was 19.4 months (95% CI, 16.6 to 22.2) while in the control group, it was 14.9 months (95% CI, 12.1 to 17.2) with a hazard ratio of 0.70 (95% CI, 0.57 to 0.85; P
Marketed by Bristol-Myers Squibb, the most common side effects if the drug include nausea, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, and pneumonia.