BRIEF—FDA accepts Bristol-Myers Squibb's sBLA for Empliciti for priority review

US pharma major Bristol-Myers Squibb today announced that the US Food and Drug Administration has accepted its supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

The FDA granted the application priority review with an action date of December 27, 2018.

The application is based on data from ELOQUENT-3, a randomized Phase II study evaluating the addition of Empliciti to pomalidomide and low-dose dexamethasone in patients with RRMM.

Data from this study were presented at the 23rd Congress of the European Hematology Association in June.

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with B-MS solely responsible for commercial activities.