Darzalex (daratumumab) is licensed for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
Daratumumab is a human monoclonal antibody that binds to the CD38 protein responsible for receptor mediated adhesion, signalling and enzymatic activity. This protein is expressed at high levels on the surface of multiple myeloma tumour cells.
The recommended dose of daratumumab is 16mg/kg administered as an intravenous infusion over 60 minutes ever week for the first 8 weeks. From weeks 9 to 24, the dosing interval is increased to every 2 weeks, followed by every 4 weeks from week 25 onwards. Treatment should be continued until disease progression or unacceptable toxicity.
To reduce the risk of infusion reactions, patients must receive premedication with an antihistamine, corticosteroid and paracetamol before each infusion. Commonly reported adverse events reported in clinical trials were infections, blood dyscrasias, decreased appetite. respiratory symptoms, pain, chills, fever and fatigue.