FDA Approves New Immunotherapy Combination for Multiple Myeloma

The U.S. Food and Drug Administration (FDA) recently approved Empliciti^® (elotuzumab) as part of a combination treatment to treat certain people with relapsed or refractory multiple myeloma (MM). Empliciti can now be used in combination with Pomalyst^® (pomalidomide) and low-dose dexamethasone, a combination known as EPd. This treatment approach is approved for people with MM who have previously received at least two prior therapies, including Revlamid^® (lenalidomide) and a proteasome inhibitor.^1,2

Increased survival time with addition of Empliciti

In clinical trials, adding Empliciti to the treatment of Pomalyst and dexamethasone increased the progression-free survival (the length of time before the disease gets worse). The three drugs in combination reduced the risk of disease progression and death by 46%, increasing progression-free survival to 10.25 months for those patients receiving the EPd combination, compared to 4.67 months for patients who received Pomalyst and dexamethasone (Pd) alone.²

Data from the clinical trials also demonstrated that the overall response rate (the percentage of people for whom the treatment was at least partially effective in slowing the disease) was doubled in those who received the three-drug combination: 53.3% of those receiving the EPd combination had a response to the treatment, compared to 26.3% of those receiving Pd.²

Addition of Empliciti increased side effects

The addition of Empliciti to the treatment regimen did increase side effects. Twenty-two percent of patients who received EPd had serious side effects, compared to 15% of those who received Pd. The most common serious side effects were pneumonia and respiratory tract infection. Some people discontinued treatment due to the significant side effects: 5% of those who received EPd stopped treatment compared to 1.8% of those who received Pd.²

The combination EPd may also cause side effects such as constipation, high blood sugar (hyperglycemia), diarrhea, bone pain, difficulty breathing, muscle spasms, swelling in the feet or legs (peripheral edema), and lowered white blood cell counts. The treatment may also cause infusion reactions, which may appear as fever, chills, or changes in blood pressure.² These are not all the possible side effects. Patients should talk to their doctor about what to expect.

How Empliciti works

Empliciti is a type of immunotherapy, a treatment that works by boosting the body’s immune system. Empliciti helps the body by identifying the myeloma cells and activating the natural killer cells in the immune system, which can then destroy the myeloma cells.³

Empliciti is given as an intravenous (IV) infusion. It was initially approved by the FDA to be used in combination with lenalidomide and dexamethasone to treat people with multiple myeloma who had previously received one to three prior therapies.^2,3