FDA Approves Elotuzumab for Relapsed, Refractory Multiple Myeloma
The FDA has approved elotuzumab (Empliciti) in combination with lenalidomide and dexamethasone for treatment of multiple myeloma.
The U.S. Food and Drug Administration (FDA) has approved elotuzumab (Empliciti) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received 1 to 3 prior therapies.1
“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.
Approval was based on findings from a clinical trial that evaluated elotuzumab plus lenalidomide and dexamethasone compared with lenalidomide plus dexamethasone in 646 patients with relapsed and/or refractory multiple myeloma. Results showed that median disease-free progression was 19.4 months with elotuzumab and 14.9 months without it. Furthermore, the overall response rate was 78.5% compared with 65.5%, respectively.
In regard to safety, the most common adverse events associated with elotuzumab are fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, and pneumonia.
Clinicians should be aware that elotuzumab may cause infusion reactions, infections, second primary malignancies, hepatotoxicity, and interference with assays used to monitor M-protein.
Elotuzumab is approved for intravenous administration every week for the first 2 cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity at a dose of 10 mg/kg. Clinicians should premedicate patients receiving elotuzumab with dexamethasone, diphenhydramine, ranitidine, and acetaminophen.
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“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,” Dr. Pazdur said. Daratumuamb (Darzalex), approved earlier this month, was the first immunotherapy approved for the treatment of patients with multiple myeloma.
- FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma [news release]. Silver Spring, MD: U.S. Food and Drug Administration; November 30, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncPressA/ucm474684.htm. Accessed December 1, 2015.