isatuximab
Isatuximab (Sarclisa) is a monoclonal antibody that targets CD38, a protein found on the surface of multiple myeloma cells. It helps the immune system recognize and destroy those cancer cells. It is used in combination with other medicines to treat multiple myeloma.
This page is based on EMA and FDA prescribing information for isatuximab injection, cross-checked with DailyMed and 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
Isatuximab is like a flag that marks multiple myeloma cells for destruction. It binds to CD38, a protein found on the surface of myeloma cells. Once attached, it sends signals to the immune system, calling in natural killer cells and other immune defenders to attack and destroy the marked cancer cells. It can also trigger the myeloma cells to self-destruct.
In simple terms
Isatuximab is a monoclonal antibody, which means it is a laboratory-made protein designed to find and attach to a specific target. In this case, it targets CD38, a protein found on the surface of multiple myeloma cells. Once isatuximab binds to CD38, it helps the immune system recognize and attack the myeloma cells. It can also directly trigger the cancer cells to die. Isatuximab is used in combination with other medicines to treat multiple myeloma, a cancer of plasma cells in the bone marrow.
In depth
Isatuximab is a humanized IgG1 monoclonal antibody directed against CD38, a type II transmembrane glycoprotein expressed on various immune cells and hematologic malignancies, including multiple myeloma. Isatuximab binds to a specific epitope on CD38 distinct from that of daratumumab. Its antitumor activity is mediated through multiple mechanisms: antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP), and direct induction of apoptosis. CD38 expression on myeloma cells has been correlated with poor prognosis. Isatuximab is used in combination with pomalidomide and dexamethasone, carfilzomib and dexamethasone, or bortezomib, lenalidomide, and dexamethasone for the treatment of multiple myeloma in various lines of therapy.
See it in motion
A schematic animation of the mechanism — simplified for clarity, not drawn to scale.
Isatuximab is like a flag that marks multiple myeloma cells for destruction.
- It binds to CD38, a protein found on the surface of myeloma cells.
- Once attached, it sends signals to the immune system, calling in natural killer cells and other immune defenders to attack and destroy the marked cancer cells.
- It can also trigger the myeloma cells to self-destruct.
- Isatuximab is used in combination with other medicines to treat multiple myeloma, a cancer of plasma cells in the bone marrow.
Target: CD38
A type II transmembrane glycoprotein expressed on various immune cells and hematologic malignancies, including multiple myeloma cells; its expression has been correlated with poor prognosis.
Approved uses
Approved uses differ by country and change over time. Always follow your local prescribing information.
Approved uses in European Union
EMA- Sarclisa is indicated in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy
- Sarclisa is indicated in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
- Sarclisa is indicated in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant
- Sarclisa is indicated in combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant
Approved uses in United States
FDA- SARCLISA is indicated in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor
- SARCLISA is indicated in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy
- SARCLISA is indicated in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT)
Approved uses in United States
DailyMed- SARCLISA is indicated in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor
- SARCLISA is indicated in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy
- SARCLISA is indicated in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT)
Official sources
The statements on this page trace back to these records.
- Sarclisa (isatuximab) — Summary of product characteristics and package leaflet, English version
European Medicines Agency
- U.S. Food and Drug Administration: isatuximab prescribing information
U.S. Food and Drug Administration
- DailyMed: isatuximab labeling
DailyMed, U.S. National Library of Medicine
- National Cancer Institute: isatuximab
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.