The injected chemotherapy drug Darzalex (daratumumab) has been approved by the U.S. Food and Drug Administration to treat people who have had at least three prior treatments for multiple myeloma, a form of blood cancer.
The disease affects germ-fighting white blood cells found in bone marrow, potentially causing a weakened immune system, and problems involving the bones and kidneys. It’s expected to be diagnosed in nearly 27,000 people and cause more than 11,000 deaths in the United States this year, the FDA said, citing estimates from the U.S. National Cancer Institute.
Darzalex is a monoclonal antibody that’s designed to help the body’s immune system fight cancer cells, the FDA said.
In clinical studies involving more than 140 people, Darzalex reduced the cancer’s spread by 29 percent to 36 percent, the agency said.
The drug’s most common side effects included allergic-like reactions, fatigue, nausea, back pain, fever and cough. More serious side effects were lowered amounts of white blood cells, red blood cells or blood platelets.
Women who are pregnant shouldn’t use the drug, and other women of childbearing age should use contraception for at least three months after treatment, the FDA warned.
Darzalex is marketed by Janssen Biotech of Horsham, Penn.
Learn more about this approval from the FDA.
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