Posted by Michael Wonder on 18 Sep 2018
EMA validates Bristol-Myers Squibb’s application for Empliciti (elotuzumab) plus pomalidomide and low dose dexamethasone in patients with multiple myeloma
18 September 2018 - Bristol-Myers Squibb today announced that the EMA has validated the Company’s type II variation application for Empliciti (elotuzumab) in combination with pomalidomide and low dose dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on the last therapy.
Validation of the application confirms the submission is complete and begins the EMA’s centralised review process.
The application is based on data from ELOQUENT-3, a randomised Phase 2 study evaluating the combination versus pomalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma.
