The FDA announced Monday the approval of Bristol-Myers Squibb's Empliciti (elotuzumab) in combination with two other therapies for the treatment of multiple myeloma in treatment-experienced patients. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, commented "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." Johnson & Johnson's Darzalex (daratumumab) was cleared by the FDA for the treatment of multiple myeloma earlier this month.
Approval of Empliciti was backed by safety and efficacy data from the ELOQUENT-2 study of 646 people whose multiple myeloma recurred or failed to respond to prior therapy. In the trial, Empliciti in combination with Celgene's Revlimid (lenalidomide) and dexamethasone was found to delay the time to disease progression compared to treatment with Revlimid and dexamethasone alone. Additionally, partial or complete tumour shrinkage was observed in 78.5 percent of patients treated with Empliciti plus Revlimid and dexamethasone, versus 65.5 percent of patients who received only Revlimid and dexamethasone.
Empliciti, which Bristol-Myers Squibb co-developed with AbbVie, was previously granted breakthrough therapy and priority review status by the FDA. The drug is expected to carry a monthly cost of about $10 000, resulting in first-year cost, including special induction cycles, of approximately $142 000.
Meanwhile, the drug is also under review in Europe, where it has been awarded accelerated assessment.
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