FDA Approves Darzalex

November 16, 2015
BioPharm International Editors

FDA grants accelerated approval for Darzalex (daratumumab) for the treatment of multiple myeloma.

On Nov. 16, 2015, FDA granted accelerated approval for Darzalex (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. The disease may result in a weakened immune system and cause other bone and kidney problems. The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the United States this year.

The most common side effects of Darzalex are infusion-related reactions, fatigue, nausea, back pain, fever, and cough. Darzalex may also result in low counts of infection-fighting white blood cells (lymphopenia, neutropenia, and leukopenia) or red blood cells (anemia), and low levels of blood platelets (thrombocytopenia).

Blood banks should be informed that patients are receiving Darzalex because the drug may interfere with certain tests that are done by blood banks, such as antibody screening, for patients who need a blood transfusion. Women who are pregnant should not use Darzalex, and women planning to become pregnant should use effective contraceptives during and for at least three months after treatment.

Source: FDA