The U.S. Food and Drug Administration (FDA) recently granted accelerated approval for Darzalex (daratumumab), a treatment that is indicated for patients with multiple myeloma who have received at least three previous treatments. With the approval, Darzalex becomes the first antibody on the market for the treatment of multiple myeloma, a type of blood cancer that occurs in infection-fighting plasma cells -- a type of white blood cell -- found in the bone marrow.
When this happens, the cancerous cells multiply, pushing healthy blood cells out of the bone marrow.
"Targeting proteins that are found on the surface of cancer cells has led to the development of important oncology treatments,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, said. “Darzalex provides another treatment option for patients with multiple myeloma who have become resistant to other therapies.”
Darzalex is an injection, administered as an infusion. Its safety and efficacy were tested in two open-label studies that used 106 patients as subjects. In the first study, 29 percent of the patients had complete or partial reduction in their tumors that lasted an average of 7.4 months. In the second study, 36 of 42 participants had complete or partial tumor reduction.
Darzalex is a product made by Janssen Biotech of Horsham, Pennsylvania.
