BRIEF—EMA validates application for Empliciti

US pharma major Bristol-Myers Squibb today announced that the European Medicines Agency (EMA) has validated the company’s type II variation application for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy.

Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.

The application is based on data from ELOQUENT-3, a randomized Phase II study evaluating the EPd combination versus pomalidomide and dexamethasone (Pd) alone in patients with relapsed or refractory multiple myeloma (RRMM).

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

Bristol-Myers and AbbVie are co-developing Empliciti, with the former solely responsible for commercial activities.

The US Food and Drug Administration has already approved Empliciti in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. It is also approved in Europe.