Last reviewed · How we verify
Hu38Sb19 (isatuximab)
Isatuximab works by binding to the CD38 protein on cancer cells, triggering a response that leads to their destruction.
Hu38Sb19, also known as isatuximab, is a CD38-directed Cytolytic Antibody developed by SANOFI AVENTIS US. It targets the lymphocyte differentiation antigen CD38, a protein found on the surface of certain cancer cells. Isatuximab is approved by the FDA for the treatment of multiple myeloma, a type of blood cancer. The drug is currently patented and owned by SANOFI AVENTIS US. It works by binding to CD38 and triggering a response that leads to the destruction of cancer cells.
At a glance
| Generic name | isatuximab |
|---|---|
| Sponsor | Sanofi |
| Drug class | CD38-directed Cytolytic Antibody |
| Target | Lymphocyte differentiation antigen CD38 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | discontinued |
| First approval | 2020 |
| Annual revenue | 500 |
Mechanism of action
Isatuximab-irfc is an IgG1-derived monoclonal antibody that binds to CD38 expressed on the surface of hematopoietic and tumor cells, including multiple myeloma cells. Isatuximab-irfc 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). Isatuximab-irfc inhibits the ADP-ribosyl cyclase activity of CD38. Isatuximab-irfc can activate natural killer (NK) cells in the absence of CD38-positive target tumor cells and suppresses CD38-positive T-regulatory cells. The combination of isatuximab-irfc and pomalidomide enhanced ADCC activity and direct tumor cell killing compared to that of isatuximab-irfc alone in vitro, and enhanced antitumor activity compared to the activity of isatuximab-irfc or pomalidomide alone in human multiple myeloma xenograft model.
Approved indications
- Multiple myeloma
Common side effects
- Pneumonia
- Upper respiratory tract infection
- Infusion-related reactions
- Diarrhea
- Febrile neutropenia
- Dyspnea
- Nausea
- Vomiting
- Hypertension
- Fatigue
- Insomnia
- Bronchitis
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 |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hu38Sb19 CI brief — competitive landscape report
- Hu38Sb19 updates RSS · CI watch RSS
- Sanofi portfolio CI