Last reviewed · How we verify
DARATUMUMAB (DARZALEX®)
Daratumumab is a monoclonal antibody that binds to CD38 on the surface of multiple myeloma cells, triggering their destruction through multiple immune mechanisms.
Daratumumab is a monoclonal antibody that binds to CD38 on the surface of multiple myeloma cells, triggering their destruction through multiple immune mechanisms. Used for Multiple myeloma (newly diagnosed), Multiple myeloma (relapsed or refractory), Light chain multiple myeloma.
At a glance
| Generic name | DARATUMUMAB (DARZALEX®) |
|---|---|
| Also known as | Experimental: Daratumumab (Darzalex®) |
| Sponsor | Hospices Civils de Lyon |
| Drug class | CD38-targeting monoclonal antibody |
| Target | CD38 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Daratumumab targets CD38, a surface antigen highly expressed on malignant plasma cells in multiple myeloma. Upon binding, it induces cell death through antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC). This multi-modal mechanism makes it effective in both newly diagnosed and relapsed/refractory multiple myeloma.
Approved indications
- Multiple myeloma (newly diagnosed)
- Multiple myeloma (relapsed or refractory)
- Light chain multiple myeloma
Common side effects
- Infusion-related reactions
- Fatigue
- Nausea
- Fever
- Cough
- Neutropenia
- Anemia
- Thrombocytopenia
Key clinical trials
- A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (PHASE3)
- A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma (PHASE1)
- A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) (PHASE3)
- Daratumumab in STK11 Mutated NSCLC (PHASE2)
- A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) (PHASE2, PHASE3)
- Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients (PHASE3)
- A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments (PHASE1)
- Daratumumab and Belatacept for Desensitization (PHASE1, PHASE2)
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 |
|---|---|
| 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:
- DARATUMUMAB (DARZALEX®) CI brief — competitive landscape report
- DARATUMUMAB (DARZALEX®) updates RSS · CI watch RSS
- Hospices Civils de Lyon portfolio CI