Bristol-Myers, AbbVie's multiple myeloma drug wins second EU nod as part of triple regimen
Less than a year after the FDA cleared Bristol-Myers Squibb $BMY and AbbVie’s $ABBV approved Empliciti injection for intravenous use in combination with Celgene’s $CELG pomalidomide (Pomalyst, or Imnovid, depending on which side of the Atlantic you are) and the steroid dexamethasone for relapsed, refractory multiple myeloma, the European Commission has followed suit.
The approval is based on data from the 117 patient-ELOQUENT-3 trial in which the triplet doubled both median progression-free survival (PFS) and overall response rate (ORR) among patients with relapsed and refractory multiple myeloma, versus pomalidomide and low-dose dexamethasone alone.
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