The European Medicines Agency (EMA) is recommending that elotuzumab (Empliciti) is fast tracked for use as a combination therapy for the treatment of patients with the rare and incurable blood cancer multiple myeloma.
The monoclonal antibody has been approved for use with lenalidomide and the anti-inflammatory medicine dexamethasone for patients who have received at least one prior therapy.
The recommendation is based on the results of a randomised, open-label phase III study that looked at the three drug combination therapy versus lenalidomide and dexamethasone dual therapy in 646 patients with relapsed or refractory multiple myeloma.
They found that the disease progressed more slowly in patients taking elotuzumab (differences in medians of 4.2 months) than patients not taking the three drug combination.
Some 78.5% of patients taking elotuzumbab with lenalidomide and dexamethasone saw a complete or partial shrinkage of their tumours compared with 65.5% in those only taking lenalidomide and dexamethasone.
The EMA’s Committee for Medicinal Products for Human Use decided to fast track the marketing authorisation of elotuzumab – which already has orphan drug status – because of the disease’s current unmet medical need. The five-year survival rate for people with this cancer undergoing treatment in the European Union is 50%.
The recommendation now goes to the European Commission for approval and, if given, it will be left to individual EU member states to agree a price and reimbursement within their own national health systems.