Empliciti earns FDA approval as combination multiple myeloma treatment

Bristol-Myers Squibb's drug Empliciti was approved by the Food and Drug Administration (FDA) Monday as a combination treatment for multiple myeloma, a form of blood cancer.

Also known as elotuzumab, Empliciti is an IV injection to be used in combination with lenalidomide and dexamethasone. It is intended for individuals with multiple myeloma who have previously been treated with one to three medications. The drug works by activating the body's immune system to destroy cancer cells.

A clinical study involving 646 individuals whose multiple myeloma either came back or unaffected with previous treatment showed that taking Empliciti with the two other aforementioned therapies delayed the progression of the disease by approximately 19.4 months compared to 14.9 months for those just taking the two therapies without Empliciti. Moreover, people taking the combination treatment saw a complete or partial shrinkage of their tumors.

“We are continuing to learn about the ways the immune system interacts with different types of cancer, including multiple myeloma," Richard Pazdur, director of the office of Hematology and Oncology products in the FDA's Center for Drug Evaluation and Research, said. “Today’s approval is the second monoclonal antibody approved to treat patients with multiple myeloma and works with another approved therapy to provide additional benefit."

Janssen Biotech's Darzalex (daratumumab) was approved by the FDA earlier this month as a treatment for patients with multiple myeloma who have tried at least three other treatments in the past.

Multiple myeloma is expected to produce more than 26,000 new diagnoses in the United States this year in addition to causing more than 11,000 deaths.