daratumumab
Darzalex (daratumumab) is a monoclonal antibody from Janssen that targets CD38, a protein abundant on myeloma cells. It flags those cells for immune destruction and is used with standard combinations across multiple myeloma, from newly diagnosed to relapsed disease.
This page is based on FDA prescribing information and the DailyMed label for daratumumab, cross-checked with the National Cancer Institute dictionary; the mechanism is explained in plain language, and analogies are used only where they stay accurate.
How it works
Explains what the medicine does in the body, not dosing, side effects, or safety.
An analogy
Myeloma cells wear a distinctive coat, CD38, on their surface. Daratumumab is a set of homing tags that sticks only to that coat. Once tagged, the cancer cells become visible targets: immune patrol cells grab the tags, drag the cells out and dismantle them, while several internal self-destruct routines are triggered at the same time.
In simple terms
Multiple myeloma is a cancer of antibody-producing plasma cells, and these cells display large amounts of a surface protein called CD38. Daratumumab binds CD38 and marks the myeloma cells for attack. Immune cells then kill the marked cells through several pathways, and the antibody can also trigger cell death directly. Adding it to standard myeloma combinations deepens responses at multiple stages of the disease.
In depth
Daratumumab is a human IgG1-kappa monoclonal antibody that binds CD38 on myeloma cells, inducing killing through complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis, as well as apoptosis via Fc-mediated cross-linking. It also depletes CD38-positive regulatory T and myeloid-derived suppressor cells, relieving immune suppression. These combined mechanisms explain its activity both as monotherapy and in combination with immunomodulatory drugs, proteasome inhibitors and chemotherapy.
See it in motion
A schematic animation of the mechanism — simplified for clarity, not drawn to scale.
Myeloma cells wear a distinctive coat, CD38, on their surface.
- Daratumumab binds CD38 and marks the myeloma cells for attack.
- Daratumumab is a set of homing tags that sticks only to that coat.
- Immune cells then kill the marked cells through several pathways, and the antibody can also trigger cell death directly.
- Adding it to standard myeloma combinations deepens responses at multiple stages of the disease.
Target: CD38
A cell-surface glycoprotein highly expressed on myeloma cells that also modulates immune signalling; marking it lets immune effector cells find and destroy the tumour cells.
Approved uses
Approved uses differ by country and change over time. Always follow your local prescribing information.
Approved uses in United States
FDA- With lenalidomide and dexamethasone, for newly diagnosed multiple myeloma in patients who are ineligible for autologous stem cell transplant, and for relapsed or refractory multiple myeloma after at least one prior therapy
- With bortezomib, melphalan and prednisone, for newly diagnosed multiple myeloma in patients who are ineligible for autologous stem cell transplant
Official sources
The statements on this page trace back to these records.
- DailyMed: Darzalex (daratumumab) label
DailyMed, U.S. National Library of Medicine
- U.S. Food and Drug Administration: daratumumab prescribing information
U.S. Food and Drug Administration
- National Cancer Institute: daratumumab
National Cancer Institute
This page explains how the medicine works — it isn’t the patient leaflet. For anything that applies to you, read the leaflet that came with your medicine or ask your pharmacist.
MedUnfold provides educational content and is not medical advice. Always follow your local prescribing information and healthcare professional.