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FDA Grants Elotuzumab Triplet Priority Review for Myeloma

Jason M. Broderick @jasoncology
Published: Thursday, Aug 23, 2018

The FDA has granted a priority review to a supplemental biologics license application (sBLA) for elotuzumab (Empliciti) for use in combination with pomalidomide (Pomalyst) and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor (PI).

The phase II ELOQUENT-3 study enrolled 117 patients with relapsed/refractory multiple myeloma who were randomized to the elotuzumab combination (n = 60) or pomalidomide and dexamethasone alone (n = 57). Elotuzumab was administered at 10 mg/kg intravenously each week during cycles 1 and 2 and at 20 mg/kg every 4 weeks thereafter. Pomalidomide was given at 4 mg orally on days 1 to 21 of each cycle plus dexamethasone weekly at 40 mg for patients ≤75 years of age or 20 mg for those >75 years.

Eligible patients had received ≥2 prior lines of therapy, including lenalidomide and a PI; patients receiving prior pomalidomide were excluded from the study. The median age of patients was 67 years and they had received a median of 3 prior treatments (range, 2-8). Prior treatments included bortezomib (100%), lenalidomide (99%), carfilzomib (21%), ixazomib (6%), and daratumumab (3%). More than half of patients (55%) had undergone stem cell transplantation and most patients were refractory to lenalidomide (87%), a PI (80%), or both (70%).
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