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FDA approves elotuzumab in combination with pomalidomide and dexamethasone for relapsed/refractory multiple myeloma

Nov 8, 2018

On 6 November 2018, the US Food and Drug Administration(FDA) approved elotuzumab (Empliciti®) in combination with pomalidomide and low dose dexamethasone (EPd) for the treatment of adult patients with relapsed/refractory multiple myeloma (MM), who have received at least two prior treatments, including lenalidomide and a proteasome inhibitor. 1,2

Elotuzumab is a monoclonal antibody that specifically targets SLAMF7 (signaling lymphocyte activation molecule family member 7), a cell-surface glycoprotein receptor, which is highly expressed in MM cells. Elotuzumab is administered by intravenous infusion. 

The approval by the FDA was based on results of the ELOQUENT-3study, a randomized, multi-center, phase II clinical trial with 117 participants. Patients treated with EPd showed a highly significant 46% reduction in risk of disease progression or death compared to patients in the control arm, treated with Pd only (hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.34–0.86, P= 0.008).

The results of this study were recently presented by Prof Meletios A. Dimopoulosat the 23 rdCongress of the European Hematology Association (EHA) 3and have just been published at the New England Journal of Medicine . A summary of the ELOQUENT-3 trialwas featured recently in the MM Hub.

Elotuzumab was first approved by the FDA in November 2015 in combination with lenalidomide and dexamethasone for patients with MM following one to three prior lines of treatment. In May 2016, it was granted approval for the same indication by the European Medicines Agency (EMA).

Expert Opinion

"This combination was very well tolerated and maybe the treatment of choice for elderly patients for whom carlfizomib based therapies maybe contraindicated.The trend for survival advantage is very encouraging."

  1. Targeted Oncology online. Elotuzumab Triplet Approved by FDA for Treatment of Myeloma. [Assessed November 08 2018].
  2. AJMC online. FDA Approves New Immunotherapy Combination for Relapsed/Refractory Multiple Myeloma. [Assessed November 08 2018].
  3. Dimopoulos MA. et al.Elotuzumab plus pomalidomide/dexamethasone (epd) vs pd for treatment of relapsed/refractory multiple myeloma (rrmm): results from the phase 2, randomized open-label eloquent-3 study. 2018 June 17; Oral Abstract #LB2606: 23rd European Hematology Association Congress, Stockholm, Sweden.