Isatuximab is an IgG1-derived monoclonal antibody that binds to CD38 expressed on the surface of hematopoietic and tumor cells, including multiple myeloma cells. Isatuximab induces apoptosis of tumor cells and activation of immune effector mechanisms including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement dependent cytotoxicity (CDC). It is used in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (MM).
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| L01FC02 | Isatuximab | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FC CD38 (Clusters of Differentiation 38) inhibitors |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| SARCLISA Concentrate for solution for infusion | European Medicines Agency (EU) | MPI, EU: SmPC | |
| SARCLISA Concentrate solution for injection | FDA, National Drug Code (US) | MPI, US: SPL/PLR |
Isatuximab is an active ingredient of these brands:
United States (US)Austria (AT)Brazil (BR)Canada (CA)Croatia (HR)Estonia (EE)Finland (FI)France (FR)Ireland (IE)Italy (IT)Japan (JP)Lithuania (LT)Netherlands (NL)Poland (PL)Romania (RO)Turkey (TR)United Kingdom (UK)Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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