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ISATUXIMAB
ISATUXIMAB is a CD38-directed Cytolytic Antibody [EPC] drug. It is currently FDA-approved (first approved 2020) for Multiple Myeloma (≥2 prior therapies), Relapsed or Refractory Multiple Myeloma (1-3 prior therapies), Newly Diagnosed Multiple Myeloma (Not Eligible for ASCT).
Isatuximab is an antibody that targets the lymphocyte differentiation antigen CD38, and it is being studied in combination with chemotherapy for various conditions, including Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Newly Diagnosed Multiple Myeloma, Relapsed Refractory Multiple Myeloma, and Relapsed Refractory Multiple Myeloma. Isatuximab is classified as an inhibitor and is used to treat these conditions.
At a glance
| Generic name | ISATUXIMAB |
|---|---|
| Drug class | CD38-directed Cytolytic Antibody [EPC] |
| Modality | Monoclonal antibody |
| Phase | FDA-approved |
| First approval | 2020 |
Approved indications
- Multiple Myeloma (≥2 prior therapies)
- Relapsed or Refractory Multiple Myeloma (1-3 prior therapies)
- Newly Diagnosed Multiple Myeloma (Not Eligible for ASCT)
Common side effects
- upper respiratory tract infection
- infusion-related reaction
- pneumonia
Drug interactions
- SARCLISA (isatuximab-irfc)
- SARCLISA (isatuximab-irfc)
Key clinical trials
- Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma (PHASE3)
- Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma (PHASE2)
- Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma (PHASE1, PHASE2)
- Study of Iberdomide, Bortezomib, Dexamethasone With Isatuximab Added on Demand for ND-NTE MM Patients (PHASE2)
- Elimination of Minimal Residual Disease After Transplant (PHASE2)
- Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma (PHASE2)
- ELISA in Relapsed/Refractory MM (PHASE2)
- Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ISATUXIMAB CI brief — competitive landscape report
- ISATUXIMAB updates RSS · CI watch RSS
Frequently asked questions about ISATUXIMAB
What is ISATUXIMAB?
What is ISATUXIMAB used for?
What drug class is ISATUXIMAB in?
When was ISATUXIMAB approved?
What development phase is ISATUXIMAB in?
What are the side effects of ISATUXIMAB?
Related
- Drug class: All CD38-directed Cytolytic Antibody [EPC] drugs
- Indication: Drugs for Multiple Myeloma (≥2 prior therapies)
- Indication: Drugs for Relapsed or Refractory Multiple Myeloma (1-3 prior therapies)
- Indication: Drugs for Newly Diagnosed Multiple Myeloma (Not Eligible for ASCT)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing