CHMP recommends Empliciti +pomalidomide + low-dose dexamethasone to treat relapsed and refractory multiple myeloma

Bristol-Myers Squibb Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency 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 randomized Phase II study evaluating pomalidomide and dexamethasone with or without Empliciti in patients with refractory or relapsed and refractory multiple myeloma. The FDA 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.