Posted by Michael Wonder on 26 Jul 2019
Bristol-Myers Squibb receives positive CHMP opinion recommending approval of Empliciti (elotuzumab) plus pomalidomide and low dose dexamethasone for treatment of patients with relapsed and refractory multiple myeloma
26 July 2019 - Bristol-Myers Squibb today announced that the CHMP of the EMA has adopted a positive opinion on a Type-II variation application for Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory 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. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
The application is based on data from ELOQUENT-3, a randomised Phase 2 study evaluating pomalidomide and dexamethasone with or without Empliciti in patients with refractory or relapsed and refractory multiple myeloma. The U.S. Food and Drug Administration approved EPd for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI, in November 2018.
