Janssen has announced that its CD38-directed monoclonal antibody Darzalex (daratumumab) has expanded its indication with a thumbs-up from the European Commission (EC) as a combination treatment for multiple myeloma in adult patients who have received at least one prior therapy.
The drug has been approved for use in combination with standards of care lenalidomide and dexamethasone, or bortezomib and dexamethasone. The approval means that Darzalex will made available very shortly to patients across Europe.
The decision to approve the drug was influenced by two Phase 3 studies which found that Darzalex reduced risk of disease progression or death when used in combination with standard of care therapies.
Dr Catherine Taylor, Haematology Therapeutic Area Lead for Janssen Europe, Middle East and Africa, explained: “This approval is an important step for people living with multiple myeloma across our region and offers some patients a new treatment option. We are encouraged by the data we have seen for daratumumab to date and will continue to investigate its potential.”