EMA recommends expanded indication for Janssen multiple myeloma drug

The European Medicines Agency’s Committee for Medicinal Products for Human Use has given its positive opinion for the use of Janssen’s CD38-directed monoclonal antibody Darzalex (daratumumab) to be expanded to include the treatment of multiple myeloma (MM) in adult patients who have undergone at least one prior therapy.

The decision was driven by the data generated by Phase 3 trials POLLUX and CASTOR which showed that "the addition of daratumumab to lenalidomide and dexamethasone significantly lengthened progression-free survival among patients with relapsed or refractory multiple myeloma", as quoted in The New England Journal of Medicine.

The drug already holds approval in the region for the treatment of relapsed and refractory MM, when used as a monotherapy in adults who have been previously treated with a proteasome inhibitor (PI) and an immunomodulatory agent and have demonstrated disease progression on the last therapy. The indication was awarded by the European Commission in May last year.

Dr Rozlyn Bekker, Medical Director at Janssen UK & Ireland, commented on the recommendation: "Janssen UK are committed to delivering innovative new therapies for patients living with complex blood cancers and we are delighted that daratumumab has been recommended for approval earlier in the treatment pathway in combination with two standard of care regimens. For this patient group, another treatment combination with the potential to prolong survival is great news, and we are pleased that this has been recognised in daratumumab."

Matt Fellows