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ARTICLE | Clinical News

FDA approves Empliciti plus pomalidomide and dexamethasone for MM

November 9, 2018 8:15 PM UTC

Bristol-Myers Squibb Co. (NYSE:BMY) said FDA approved an sBLA for Empliciti elotuzumab in combination with pomalidomide and dexamethasone to treat adults with multiple myeloma patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. FDA approved the combo ahead of its Dec. 27 PDUFA date. The application had Priority Review.

In the open-label Phase II ELOQUENT-3 trial, Empliciti plus pomalidomide and low-dose dexamethasone met the primary endpoint of improving median progression-free survival (PFS) vs. pomalidomide and dexamethasone alone (10.3 vs. 4.7 months, p=0.0078) (see "BMS's Empliciti Meets in Phase II to Treat MM")...