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.
Updated trial data — with a minimum follow-up of 18.3 months — were presented at the European Hematology Association (EHA) this year. In this exploratory analysis, a total of 40 (67%) patients were alive in the triplet arm and 29 (51%) patients were alive in the comparator arm, Bristol-Myers noted on Tuesday, adding that median overall survival was not reached for the triplet arm.
Empliciti, an immunostimulatory antibody, was initially approved by the FDA in 2015 in combination with Celgene’s lenalidomide (Revlimid) and dexamethasone for multiple myeloma patients whose disease has progressed despite, one to three prior therapies — Europe came to the same conclusion the year after. In 2018, Empliciti was cleared by the FDA for use in combination with pomalidomide and dexamethasone, to treat patients who have received at least two prior therapies.
In the first half of this year, Empliciti earned $174 million in global sales. Revlimid generated about $5.3 billion and Pomalyst/Imnovid made about $1.2 billion over the same period.
Multiple myeloma is cancer of the plasma cells — normal plasma cells are found in the bone marrow and function as a key component of the immune system. In Europe, about 40,000 people were diagnosed with the disease in 2015, and this number is predicted to climb to almost 46,000 by 2025, according to statistics cited by Myeloma Patients Europe, a Brussels-based non-profit Myeloma patient group.
Social image: Bone marrow aspirate cytology of multiple myeloma, Shutterstock