The U.S. Food and Drug Administration has given approval to the use of the drug Empliciti (elotuzumab) in combination with two other therapies for blood cancer or multiple myeloma patients who have undergone one to three prior treatments.
The approval of Empliciti, a drug co-produced by American pharmaceutical company Bristol-Myers Squibb and AbbVie, Inc., is based on a randomized clinical study which exhibited how combining Empliciti with dexamethasone (ERd) reduced the risk of the progression of multiple myeloma in patients by 30 percent compared to the use of ERd alone.
Along with ERd, the FDA also approved the combination of Revlimid (lenalidomide) with Empliciti.
"We are continuing to learn about the ways the immune system interacts with different types of cancer, including multiple myeloma," said Dr. Richard Pazdur of the FDA's Center for Drug Evaluation and Research.
Pazdur explained that Empliciti is the second monoclonal antibody authorized for multiple myeloma treatments. Earlier in November, the drug Darzalex (daratumumab) was approved by the FDA for blood cancer therapies.
In the randomized clinical trial, 646 patients whose multiple myeloma relapsed after treatment or who did not respond to previous therapies were tested. Patients who were taking Empliciti with dexamethasone and Revlimid experienced a delay in the amount of time before their condition worsened, with 19.4 months compared to 14.9 months for patients who were taking only dexamethasone or Revlimid.
About 78 percent of those taking the Empliciti combination experienced either a partial or complete shrinkage of their cancer tumors. In comparison, patients who were taking only dexamethasone and Revlimid saw 65.5 percent tumor shrinkage.
Multiple myeloma occurs in white blood cells within the bone marrow. Approximately 26,850 new cases of multiple myeloma and 11,420 deaths related to the disease will be recorded in the United States this year, according to the National Cancer Institute.
Chief Scientific Officer Francis Cuss of Bristol-Myers Squibb explained that Empliciti directly activates the immune system of multiple myeloma patients to destroy and attack the cancer cells.
Empliciti costs about $10,000 for biweekly doses. It is available for injection in 400 mg and 300 mg vials.
The drug's most common side effects are diarrhea, fatigue, fever, cough, constipation, nerve damage, infection of the throat and nose, infection of the upper respiratory tract, pneumonia and decreased appetite, the FDA said.
Meanwhile, experts believe that the approval of Empliciti offers hope for the multiple myeloma community who urgently need a treatment option which extends the time patients live without their condition progressing.
