European Commission approves second Empliciti combo

Following a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) last month, the European Commission (EC) has now approved Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy.

This approval, granted to pharma major Bristol-Myers Squibb (NYSE: BMY), is based on data from the ELOQUENT-3 trial in which EPd doubled both median progression-free survival (PFS) and overall response rate (ORR) among patients with relapsed and refractory multiple myeloma versus pomalidomide, Celgene's (Nasdaq: CELG) Pomalyst, and low-dose dexamethasone (Pd) alone.

Empliciti was first approved in the European Union (combined with lenalidomide – Celgene’s Revlimid -and dexamethasone) for adults with MM who have received at least one prior line of therapy.