The application now will be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).
Bristol-Myers Squibb senior vice president, head of development, oncology Michael Giordano said: "Today’s positive CHMP recommendation means we are one step closer to offering a new type of treatment for patients in Europe with multiple myeloma who have received at least one prior therapy.
"We look forward to the European Commission’s decision and the opportunity to extend our leading Immuno-Oncology science to patients with multiple myeloma."
The CHMP positive opinion is based on data from the Phase 3, open-label ELOQUENT-2 study, which evaluated Empliciti in combination with lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd) alone. The results of this trial showed a 30% reduction in the risk of disease progression or death with ERd compared to Rd alone and, at the two year time point, ERd delivered a 52% relative improvement in progression-free survival.
The most common adverse reactions in ERd and Rd, respectively (>20%) were fatigue (61.6%, 51.7%), diarrhea (46.9%, 36.0%), pyrexia (37.4%, 24.6%), constipation (35.5%, 27.1%), cough (34.3%, 18.9%), peripheral neuropathy (26.7%, 20.8%), nasopharyngitis (24.5%, 19.2%), upper respiratory tract infection (22.6%, 17.4%), decreased appetite (20.8%, 12.6%) and pneumonia (20.1%, 14.2%). These results were published in The New England Journal of Medicine on June 2, 2015.
About Empliciti
Empliciti is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities.
SLAMF7 is also expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.
Empliciti has a dual mechanism-of-action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway.
Empliciti also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity.
On November 30, 2015, the U.S. Food and Drug Administration approved Empliciti in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received one to three prior therapies. The safety and efficacy of Empliciti is still being evaluated by other health authorities.
Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.