BMS’ Elotuzumab Gets Accelerated Reviews for Multiple Myeloma

The FDA has granted priority review for Bristol-Myers Squibb and AbbVie’s Empliciti for the treatment of multiple myeloma in patients who have received one or more previous therapies — giving it a PDUFA date of Feb. 29, 2016.

Empliciti (elotuzumab) received breakthrough designation from the FDA in 2014. It also snagged an accelerated assessment by the European Medicines Agency.

The FDA submission is based on data from two studies: the Phase 3 Eloquent-2 trial evaluating Empliciti in combination with lenalidomide and dexamethasone versus those two drugs alone, and the Phase 2 CA204-009 trial assessing the candidate plus bortezomib and dexamethasone versus those drugs alone.

Results of the Eloquent-2 trial, reported in May, showed the Empliciti combo extends remission for multiple myeloma by about four and a half months, compared with standard care alone.

An anti-CS1 antibody, Empliciti binds to a protein on myeloma cells and kills them. The drug is part of a growing group of cancer treatments that trigger the body’s immune system to fight tumors.

BMS and AbbVie are co-developing the drug, with BMS solely responsible for commercialization. — Kellen Owings