Myeloma Minute: FDA Approves Elotuzumab
IMF Applauds FDA Approval of Empliciti (elotuzumab) for Treatment of Relapsed Multiple Myeloma
The International Myeloma Foundation (IMF) applauds today’s approval by the US Food and Drug Administration (FDA) of Empliciti (elotuzumab), a monoclonal antibody developed by Bristol-Myers Squibb and AbbVie, for use in combination with lenalidomide and dexamethasone to treat multiple myeloma patients who have received at least one prior therapy.
“With the FDA’s action, patients now have another option to turn to when other treatments have failed,” said IMF President Susie Novis Durie. “Having additional treatment options for patients, is something the IMF has worked tirelessly to achieve for 25 years.”
IMF Chairman Dr. Brian Durie described elotuzumab as “a new class of agent which recruits the activity of natural killer (NK) cells to attack myeloma.” Today’s FDA approval, he said, is “a very important new addition to the myeloma arsenal.”
Clinical trials of elotuzmab showed that the drug works more effectively in combination with the immunomodulatory agent Revlimid® and the steroid dexamethasone than alone. In a phase III study of 646 patients, Dr. Sagar Lonial of Emory University found that progression free survival (PFS) increased by nearly 5 months in patients who had received 1-3 prior therapies and who were treated with elotuzumab combined with Revlimid®/dexamethasone.
According to the study, the benefit was durable: PFS in the elo/Revlimid®/dex-treated arm was 68% at one year and 41% at two years, compared to 57% at one year and 27% at two years in the Revlimid®/dex-treated patients. “It was particularly striking that the difference between the elotuzumab and control groups seems to get bigger over time, which really speaks to the power of this immune-based approach,” said Dr. Lonial.
The results of the ELOQUENT-2 trial were presented by Dr. Lonial at the 2015 annual meeting of the American Society of Clinical Oncology (ASCO), in this IMF video interview, and published in the New England Journal of Medicine in June.
For more information, please contact the IMF InfoLine team toll free at (800) 452-CURE (2873) or by email at [email protected].