Posted from: Tuesday, December 11, 2018 - 04:59 PM - Present

New Indication Approved for Empliciti

November 6, 2018 – The U.S. FDA has approved a new indication for Empliciti® (elotuzumab) intravenous injection, manufactured by Bristol-Myers Squibb. It is now indicated for use in combination with pomalidomide and dexamethasone to treat adult patients who have multiple myeloma and have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

Multiple myeloma affects plasma cells, causing them to create an abnormal protein and to crowd out normal blood cells. Patients may experience anemia (low red blood cells), thrombocytopenia (low blood platelets), and leukopenia (low white blood cells). Patients may also experience kidney problems, infection, bone loss, and excess calcium in the bloodstream. An estimated 30,770 new cases will be diagnosed in the United States in 2018, while approximately 12,770 patients will die of the disease.

In clinical trials, Empliciti combined with pomalidomide and dexamethasone (EPd) reduced the risk of disease progression by 46%. EPd delivered a mean 10.25 months of progression-free survival (PFS) compared to 4.6 months for patients treated with pomalidomide and dexamethasone (Pd) alone. Recommended dosing for Empliciti when used with Pd is 10 mg/kg administered by intravenous injection every week for the first two cycles, and 20 mg/kg every four weeks thereafter until disease progression or unacceptable toxicity.

Empliciti first received FDA approval in 2015. In addition to the new indication, it is approved for use in combination with lenalidomide and dexamethasone to treat adult patients who have multiple myeloma and have received one to three prior therapies.

 

Last Updated Monday, January 21, 2019 - 12:28 PM.