National Institute for Health and Care Excellence (NICE) has recommended daratumumab (Darzalex) as a treatment option for relapsed or refractory multiple myeloma.
Daratumumab monotherapy is recommended for treatment of adults with relapsed and refractory multiple myeloma previously treated with at least 3 therapies including a proteasome inhibitor and an immunomodulator, and the disease has progressed on the last therapy. Daratumumab is a monoclonal antibody which specifically binds to the CD38 protein and subsequently kills multiple myeloma cells.
The recommended dose for daratumumab is 16 mg/kg body weight administered by intravenous infusion as per the following schedule:
- Weeks 1-8: weekly.
- Weeks 9-24: every 2 weeks.
- Week 25 onwards: every 4 weeks.
Therapy is to be continued until evidence of disease progression. Most common adverse reactions observed during therapy are infusion-related reactions including throat irritation, dyspnoea, nausea and cough.
The drug has been approved for use within the Cancer Drugs Fund and is to be used only when the conditions in the managed access agreement are followed. The recommendation should not affect patients whose treatment with the drug was started before publication of the guidance.
