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Daratumumab SC: daratumumab + rHuPH20
Daratumumab SC: daratumumab + rHuPH20 is a CD38-targeting monoclonal antibody Small molecule drug developed by Janssen Research & Development, LLC. It is currently in Phase 3 development for Multiple myeloma (newly diagnosed and relapsed/refractory), Light chain myeloma. Also known as: JNJ-54767414.
Daratumumab is a monoclonal antibody that binds to CD38 on multiple myeloma cells and triggers their destruction through multiple immune mechanisms, while rHuPH20 enhances subcutaneous bioavailability.
Daratumumab is a monoclonal antibody that binds to CD38 on multiple myeloma cells and triggers their destruction through multiple immune mechanisms, while rHuPH20 enhances subcutaneous bioavailability. Used for Multiple myeloma (newly diagnosed and relapsed/refractory), Light chain myeloma.
At a glance
| Generic name | Daratumumab SC: daratumumab + rHuPH20 |
|---|---|
| Also known as | JNJ-54767414 |
| Sponsor | Janssen Research & Development, LLC |
| Drug class | CD38-targeting monoclonal antibody |
| Target | CD38 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Daratumumab targets CD38, a surface antigen highly expressed on multiple myeloma cells, inducing cell death through antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC). The addition of recombinant human hyaluronidase (rHuPH20) enables subcutaneous administration by temporarily breaking down hyaluronic acid in subcutaneous tissue, improving drug distribution and reducing infusion time compared to intravenous formulations.
Approved indications
- Multiple myeloma (newly diagnosed and relapsed/refractory)
- Light chain myeloma
Common side effects
- Infusion-related reactions
- Neutropenia
- Anemia
- Thrombocytopenia
- Fatigue
- Upper respiratory tract infection
- Pneumonia
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)
- 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)
- INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma (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 SC: daratumumab + rHuPH20 CI brief — competitive landscape report
- Daratumumab SC: daratumumab + rHuPH20 updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI
Frequently asked questions about Daratumumab SC: daratumumab + rHuPH20
What is Daratumumab SC: daratumumab + rHuPH20?
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What drug class is Daratumumab SC: daratumumab + rHuPH20 in?
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Related
- Drug class: All CD38-targeting monoclonal antibody drugs
- Target: All drugs targeting CD38
- Manufacturer: Janssen Research & Development, LLC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Multiple myeloma (newly diagnosed and relapsed/refractory)
- Indication: Drugs for Light chain myeloma
- Also known as: JNJ-54767414
- Compare: Daratumumab SC: daratumumab + rHuPH20 vs similar drugs
- Pricing: Daratumumab SC: daratumumab + rHuPH20 cost, discount & access