FDA Approves Elotuzumab in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma

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The U.S. Food and Drug Administration (FDA) has granted approval for elotuzumab (Empliciti) in combination with two other therapies to treat patients with multiple myeloma who have received one to three prior 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 Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “[The recent] approval is the second monoclonal antibody approved to treat patients with multiple myeloma and works with another approved therapy to provide additional benefit.” Daratumumab (Darzalex), approved earlier in November, is the only other FDA-approved monoclonal antibody for the treatment of patients with multiple myeloma.

Elotuzumab activates the body’s immune system to attack and kill multiple myeloma cells. It is approved in combination with another FDA-approved treatment for multiple myeloma, lenalidomide (Revlimid), and the corticosteroid dexamethasone.


The safety and efficacy of elotuzumab were tested in the ELOQUENT-2 trial, a randomized, open-label clinical study of 646 participants with either relapsed disease or whose multiple myeloma had not responded to previous treatment. Those taking elotuzumab plus lenalidomide and dexamethasone experienced a progression-free survival of 19.4 months compared to participants taking only lenalidomide and dexamethasone (14.9 months). Additionally, the overall response rate of those taking elotuzumab with lenalidomide and dexamethasone was 78.5%, compared to 65.5% in those taking only lenalidomide/dexamethasone.

The most common side effects of elotuzumab are fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, and pneumonia. ■




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