The Food and Drug Administration has granted priority review to elotuzumab (Empliciti) for treatment of patients with relapsed/refractory multiple myeloma.
Bristol-Myers Squibb is seeking approval for elotuzumab in combination with pomalidomide and low-dose dexamethasone to treat patients with relapsed/refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
Elotuzumab is already approved for use in combination with lenalidomide and dexamethasone to treat multiple myeloma patients who have received between one and three prior therapies.
The elotuzumab application is supported by data from ELOQUENT-3, a randomized, phase 2 study that evaluated the addition of elotuzumab to pomalidomide and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma.
Researchers presented findings from this study at the annual congress of the European Hematology Association in June 2018.
The overall response rate was 53% in the elotuzumab, pomalidomide, and low-dose dexamethasone (EPd) arm and 26% in the pomalidomide and low-dose dexamethasone (Pd) arm. The median progression-free survival was 10.3 months in the EPd arm and 4.7 months in the Pd arm (hazard ratio, 0.54; P = .0078), the researchers reported.
The researchers also reported that adverse events in the EPd arm were consistent with expectations based on previous results with elotuzumab and pomalidomide regimens.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The priority review typically shortens the time to an approval decision by a few months. The agency is expected to make a decision on elotuzumab by Dec. 27, 2018.
Bristol-Myers Squibb and AbbVie are codeveloping elotuzumab, with Bristol-Myers Squibb solely responsible for commercial activities.