FDA approval for Empliciti triplet combo therapy in multiple myeloma

The US Food and Drug Administration has approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and 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.1

Bristol-Myers Squibb’s (NYSE: BMY) supplemental Biologics License Application (sBLA) for Empliciti for this combination was accepted for review by the FDA in August this year. At that time, the agency granted the application priority review with an action date of December 27, 2018, so the approval coming more than seven weeks earlier than expected is a nice bonus for Bristol-Myers and its partner, AbbVie (NYSE: ABBV).

In ELOQUENT-3, a randomized, open-label, Phase II trial, EPd demonstrated benefit in patients with relapsed or refractory multiple myeloma, doubling both median progression-free survival (PFS) and overall response rate (ORR) versus pomalidomide and dexamethasone (Pd).