FDA Grants Accelerated Approval For J&J's Cancer Drug Darzalex

(RTTNews) - The U.S. Food and Drug Administration has granted accelerated approval for Johnson & Johnson 's (JNJ) Darzalex or daratumumab to treat patients with multiple myeloma who have received at least three prior treatments.

Darzalex is the first monoclonal antibody approved for treating multiple myeloma, a form of blood cancer that occurs in infection-fighting plasma cells found in the bone marrow.

These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow. As a result, the immune system may be weakened and other bone or kidney problems may occur.

The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the U.S. this year.

Darzalex injection is given as an infusion. It is a monoclonal antibody that works by helping certain cells in the immune system attack cancer cells.

The safety and efficacy of Darzalex were demonstrated in two open-label studies. Its most common side effects were infusion-related reactions, fatigue, nausea, back pain, fever and cough.

Richard Pazdur, M.D., 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."