Overview
Isatuximab (formerly SAR650984) is a humanized, IgG1-derived monoclonal antibody (mAb) produced from a Chinese hamster ovary (CHO) cell line. Structurally, isatuximab is comprised of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains. It is a cytolytic antibody targeted against CD38, a glycoprotein found on the surface of some immune cells that is highly expressed by malignant plasma cells in multiple myeloma. Along with daratumumab, another anti-CD38 mAb, isatuximab constitutes a novel treatment modality for patients with difficult-to-treat multiple myeloma. Following three consecutive years on the yearly "Antibodies to watch" list published in "mAb", a peer-reviewed scientific journal dedicated to antibody research, isatuximab was granted Orphan Drug designation and approved on March 2nd, 2020, for the treatment of multiple myeloma. It is manufactured by Sanofi-Aventis U.S. under the brand name Sarclisa.
Indication
Isatuximab is indicated in combination with pomalidomide and dexamethasone for the treatment of multiple myeloma in adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. It is also indicated in combination 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.
Associated Conditions
- Multiple Myeloma (MM)
- Refractory Multiple Myeloma
- Relapsed Multiple Myeloma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/01 | Not Applicable | Not yet recruiting | PETHEMA Foundation | ||
2025/03/25 | Phase 2 | Not yet recruiting | |||
2025/02/18 | Phase 2 | Not yet recruiting | |||
2024/10/18 | Phase 2 | Recruiting | Goethe University | ||
2024/07/24 | Phase 2 | Not yet recruiting | |||
2024/04/10 | Phase 2 | Recruiting | |||
2024/01/22 | Phase 3 | Recruiting | University of Heidelberg Medical Center | ||
2024/01/12 | Phase 1 | Recruiting | Elvira Umyarova | ||
2023/11/07 | Phase 1 | Recruiting | |||
2023/06/28 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Sanofi-Aventis U.S. LLC | 0024-0654 | INTRAVENOUS | 100 mg in 5 mL | 6/16/2025 | |
Sanofi-Aventis U.S. LLC | 0024-0656 | INTRAVENOUS | 500 mg in 25 mL | 6/16/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 5/30/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
SARCLISA CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML | SIN16630P | INFUSION, SOLUTION CONCENTRATE | 20mg/mL | 10/17/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Isatuximab Injection | 国药准字SJ20250002 | 生物制品 | 注射剂 | 1/8/2025 | |
Isatuximab Injection | 国药准字SJ20250001 | 生物制品 | 注射剂 | 1/8/2025 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
SARCLISA isatuximab 100 mg/5 mL concentrated injection vial | 319086 | Medicine | A | 5/6/2020 | |
SARCLISA isatuximab 500 mg/25 mL concentrated injection vial | 319085 | Medicine | A | 5/6/2020 |
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