The European Commission has approved Bristol-Myers Squibb’s Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone (EPd) to treat patients with refractory multiple myeloma.
The drug received approval for administration to multiple myeloma patients who have undergone at least two therapies, which include proteasome inhibitor (PI) and lenalidomide and have also shown disease progression on the last session.
Bristol-Myers Squibb noted that the EC approval comes after the review of the data obtained from the Phase II ELOQUENT-3 trial.
In the trial, the drug doubled the overall response rate (ORR) and median progression-free survival (PFS) in patients when compared to just pomalidomide and low-dose dexamethasone (Pd).
Bristol-Myers Squibb oncology development head Fouad Namouni said: “Multiple myeloma is a frequently recurring disease and the chance it will return after initial treatment is a heavy burden for patients to carry.
“We are proud that the European Commission has again recognised the role of Empliciti in helping European patients with multiple myeloma by approving a second Empliciti-based regimen in the relapsed and refractory setting.”
ELOQUENT-3 trial results have shown that EPd can increase the survival of pre-treated multiple myeloma patients without disease progression.
As part of the trial, 117 patients were given both the drugs at random; 60 patients received EPd, while 57 patients received Pd.
The trial’s primary endpoint PFS was 10.25 months for randomised EPd patients, while for patients with only Pd, it was 1.47 months.
ORR, the secondary endpoint for EPd, was 53.3% while that for Pd was 26.3%.
In November last year, the US Food and Drug Administration (FDA) approved EPd for the treatment of adult patients with multiple myeloma.