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Empliciti approved for previously treated multiple myeloma
The FDA approved elotuzumab in combination with two other therapies for treatment of patients with multiple myeloma who received one to three prior therapies.
Elotuzumab (Empliciti, Bristol-Myers Squibb) — which activates the body’s immune system to attack and kill multiple myeloma cells — is indicated for use in combination with lenalidomide (Revlimid, Celgene) and dexamethasone.
“We are continuing to learn about the ways the immune system interacts with different types of cancer, including multiple myeloma,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
The FDA based the approval in part on safety and efficacy data from an open-label, randomized study that included 646 patients with myeloma who either did not respond to or relapsed after prior treatment.
Researchers assigned patients to lenalidomide plus dexamethasone with or without elotuzumab.
Patients assigned elotuzumab experienced longer median PFS (19.4 months vs. 14.9 months). Researchers also reported a higher rate of complete or partial tumor shrinkage in the elotuzumab group (78.5% vs. 65.5%).
The most common adverse events associated with elotuzumab included fatigue, peripheral neuropathy, pneumonia and constipation.
Elotuzumab was the second monoclonal antibody to receive FDA approval for patients with myeloma. The other agent, daratumumab (Darzalex, Janssen), received accelerated approval 2 weeks earlier for use in patients who received at least three prior treatments.