Multiple Myeloma Drug Recommended for Approval in Europe

Elotuzumab (Empliciti) was granted a positive opinion by the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP), which recommended approval as a combination therapy in treating multiple myeloma patients.

Empliciti is an immunostimulatory antibody that targets the Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), which is a cell-surface glycoprotein.

“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,” said Senior Vice President of Bristol-Myers Squibb, Michael Giordano, MD. “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 positive opinion is based off of results from the phase 3 open-label ELOQUENT-2 study. The study compared how Empliciti worked in combination with lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd) alone.

The results of the study, published in The New England Journal of Medicine, showed that there was a 30% reduction with the Empliciti combination in disease progression risk or death compared with Rd alone. After 2 years, ERd showed a 52% relative improvement in the progression free survival rate.

The most common side effects and negative reactions to ERd and Rd (>20%) was 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%), respectively.

The next step in the process is for the application to be reviewed by the European Commission, who can approve or deny medications for the European Union.