Empliciti approved by FDA for treatment of multiple myeloma
“We are continuing to learn about the ways the immune system interacts with different types of cancer, including multiple myeloma," said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “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."
The new therapy is indicated for patients who have been treated for MM with one or more medications that have not been effective.
A test of the safety and effectiveness of Empliciti was conducted using as subjects 646 patients with recurring or non-responsive MM. When using the drug, patients lived for 19.4 months before their disease became more severe, compared with 14.9 months among patients who did not use the drug.
According to statistics from the National Cancer Institute, 26,850 new cases of multiple myeloma will be diagnosed this year, and 11,240 patients will die as a result of the disease.
Empliciti is an activator of the body's immune systems than attacks and destroys MM cells. It is to be used in combination with two other drugs, Revlimid (lenalidomide) and dexamethasone (a type of corticosteroid).
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