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Daratumumab/rHuPH20
Daratumumab is a monoclonal antibody that targets CD38 on multiple myeloma cells, while rHuPH20 is a recombinant human hyaluronidase that enhances subcutaneous delivery by breaking down hyaluronic acid in the extracellular matrix.
Daratumumab is a monoclonal antibody that targets CD38 on multiple myeloma cells, while rHuPH20 is a recombinant human hyaluronidase that enhances subcutaneous delivery by breaking down hyaluronic acid in the extracellular matrix. Used for Multiple myeloma (subcutaneous formulation in phase 3 development).
At a glance
| Generic name | Daratumumab/rHuPH20 |
|---|---|
| Also known as | Darzalex |
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Drug class | Monoclonal antibody with recombinant human hyaluronidase |
| Target | CD38 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Daratumumab binds to CD38, a surface antigen highly expressed on multiple myeloma cells, triggering immune-mediated cell death through antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and antibody-dependent cellular phagocytosis (ADCP). The rHuPH20 enzyme facilitates rapid subcutaneous absorption by temporarily degrading hyaluronic acid in subcutaneous tissue, allowing for faster and more complete drug delivery compared to standard subcutaneous administration.
Approved indications
- Multiple myeloma (subcutaneous formulation in phase 3 development)
Common side effects
- Infusion reactions
- Infection
- Anemia
- Thrombocytopenia
- Fatigue
Key clinical trials
- Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma (PHASE2)
- Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse (PHASE2)
- Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing (PHASE2)
- A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma (PHASE3)
- Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial (PHASE3)
- Selvigaltin With Standard of Care Treatment for the Treatment of Relapsed/Refractory Multiple Myeloma (PHASE1)
- Home Based Daratumumab Administration for Patients With Multiple Myeloma (PHASE4)
- Study of Daratumumab in Patients With Mild to Moderate Alzheimer's Disease (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/rHuPH20 CI brief — competitive landscape report
- Daratumumab/rHuPH20 updates RSS · CI watch RSS
- Masonic Cancer Center, University of Minnesota portfolio CI