Daratumumab (first antibody approved for multiple myeloma)
~ Dr. Kumudini Rao
Daratumumab (Darzalex) is a monoclonal antibody targeted against CD38, which is highly and uniformly expressed on myeloma cells and expressed at low levels on normal lymphoid and myeloid cells. Daratumumab received accelerated approval by the US FDA 11/2015 for patients with Multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent. Drugs in the immunomodulatory class include Revlimid (lenalidomide), thalidomide (Thalomid), and Pomalyst (pomalidomide, Imnovid). Drugs in the proteasome inhibitor class include Velcade (bortezomib) and Kyprolis (carfilzomib). This definitely opens up more options for patients who received previous treatments.
Daratumumab is the first human CD38 monoclonal antibody to treat cancer and the first therapeutic antibody approved for the treatment of multiple myeloma.
The safety and efficacy of Darzalex were demonstrated in two open-label studies. In one study of 106 participants receiving Darzalex, 29 percent of patients experienced a complete or partial reduction in their tumor burden, which lasted for an average of 7.4 months. In the second study of 42 participants receiving Darzalex, 36 percent had a complete or partial reduction in their tumor burden.
The most common side effects of Darzalex were infusion-related reactions, fatigue, nausea, back pain, fever and cough. Darzalex may also result in low counts of infection-fighting white blood cells (lymphopenia, neutropenia, and leukopenia) or red blood cells (anemia) and low levels of blood platelets (thrombocytopenia).
Blood banks should be informed that patients are receiving Darzalex because the drug may interfere with certain tests that are done by blood banks (such as antibody screening) for patients who need a blood transfusion.
We have used monoclonal antibodies in several different cancers with good results and hope the same for multiple myeloma.