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FDA grants priority review to Empliciti combination for multiple myeloma
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The FDA granted priority review designation to elotuzumab in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma, according to the manufacturer.
The designation pertains to patients who have received at least two prior therapies, including lenalidomide (Revlimid, Celgene) and a proteasome inhibitor.
The FDA set an action date of December 27 for the elotuzumab (Empliciti; Bristol-Myers Squibb, AbbVie) combination.
“This file acceptance is an important step in Bristol-Myers Squibb’s ongoing efforts to advance treatment options for patients with relapsed/refractory multiple myeloma,” Jeffrey Jackson, PhD, hematology development lead at Bristol-Myers Squibb, said in a company-issued press release. “Given the need for new, effective treatment options in this patient population, we look forward to working with the FDA with the hope of bringing this combination to patients with relapsed/refractory multiple myeloma whose disease progressed on previous therapies as quickly as possible.”
The FDA based the priority review designation on results from the phase 2 ELOQUENT-3 trial. The analysis included 117 patients with relapsed/refractory multiple myeloma who received two or more prior therapies and were refractory to lenalidomide and a proteasome inhibitor.
Researchers randomized patients 1:1 to pomalidomide (Pomalyst, Celgene) and low-dose dexamethasone alone (n = 57) or with elotuzumab (n = 60).
Treatment continued in 28-day cycles until disease progression or unacceptable toxicity.
The addition of elotuzumab conferred a 46% reduction in risk for disease progression (HR = 0.54; 95% CI, 0.34-0.86). The median PFS was 10.3 months (95% CI, 5.6 to not estimable) among patients receiving the elotuzumab combination compared with 4.7 months (95% CI, 2.8-8.2) among patients in the control arm.
Researchers observed a PFS benefit regardless of whether patients received two to three prior lines of therapy (HR – 0.55; 95% CI, 0.31-0.98), or four or more prior lines of therapy (HR = 0.51; 95% CI, 0.24-1.08).
The safety profiled was consistent with previous trials of elotuzumab and pomalidomide.