The agency said Monday it has given the go-ahead to Darzalex (daratumumab) for patients who have already undergone at least three prior standard treatments for the disease. The blood cancer affects infection-fighting plasma cells in the bone marrow.
Darzalex, which is given as an infusion, is a monoclonal antibody that assists the immune system in attacking cancer cells. J&J licensed the worldwide rights to the medicine from Genmab, a Danish biotechnology company.
In one study, which involved 106 patients, tumors shrank or were no longer detectable in 29% of those taking Darzalex, while the benefit lasted an average of 7.4 months. In another trial, which had 42 patients, 36% of those taking the J&J/Genmab treatment experienced a complete or partial reduction in tumors.
Researchers have said it is the first antibody medicine to demonstrate effectiveness against myeloma without having to be combined with other drugs. Common side effects have included fatigue, fever and cough, nausea, and back pain.