The European Commission granted approval to Genmab A/S and Johnson & Johnson's Darzalex in combination with other medications to treat adult patients with a type of blood cancer.
Darzalex, or daratumumab, was approved in combination with chemotherapy drugs bortezomib and thalidomide plus corticosteroid medicine dexamethasone to treat adult patients with newly diagnosed multiple myeloma.
Multiple myeloma is cancer that forms in a type of white blood cell called a plasma cell. It causes cancer cells to accumulate in the bone marrow, where they crowd out healthy blood cells.
The approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, in December 2019.
The therapy's approval was based on data from a late-stage study called Cassiopeia, which showed that the combination of Darzalex and chemotherapy was better than chemotherapy alone in treating multiple myeloma.
Genmab granted J&J an exclusive worldwide license to develop, manufacture and commercialize Darzalex in 2012.