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Arm B: Daratumumab Hyaluronidase
Arm B: Daratumumab Hyaluronidase is a CD38-targeting monoclonal antibody Small molecule drug developed by PrECOG, LLC.. It is currently in Phase 3 development for Multiple myeloma (newly diagnosed and relapsed/refractory), Light chain myeloma. Also known as: DARZALEX FASPRO™.
Daratumumab is a monoclonal antibody that binds to CD38 on multiple myeloma cells and triggers their destruction through multiple immune mechanisms, while hyaluronidase enables subcutaneous administration by breaking down hyaluronic acid in subcutaneous tissue.
Daratumumab is a monoclonal antibody that binds to CD38 on multiple myeloma cells and triggers their destruction through multiple immune mechanisms, while hyaluronidase enables subcutaneous administration by breaking down hyaluronic acid in subcutaneous tissue. Used for Multiple myeloma (newly diagnosed and relapsed/refractory), Light chain myeloma.
At a glance
| Generic name | Arm B: Daratumumab Hyaluronidase |
|---|---|
| Also known as | DARZALEX FASPRO™ |
| Sponsor | PrECOG, 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 via antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC). The addition of recombinant human hyaluronidase allows for subcutaneous delivery instead of intravenous infusion, improving patient convenience and reducing infusion-related reactions while maintaining the same therapeutic efficacy.
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
- Injection site reactions
Key clinical trials
- 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 to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments (PHASE3)
- Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease (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)
- Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma (PHASE3)
- Testing the Investigational Agent Combination of Daratumumab, Bortezomib, and Dexamethasone Compared to the Usual Treatment of Cyclophosphamide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Patients With Kidney Failure (PHASE2)
- A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM) (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:
- Arm B: Daratumumab Hyaluronidase CI brief — competitive landscape report
- Arm B: Daratumumab Hyaluronidase updates RSS · CI watch RSS
- PrECOG, LLC. portfolio CI
Frequently asked questions about Arm B: Daratumumab Hyaluronidase
What is Arm B: Daratumumab Hyaluronidase?
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Related
- Drug class: All CD38-targeting monoclonal antibody drugs
- Target: All drugs targeting CD38
- Manufacturer: PrECOG, 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: DARZALEX FASPRO™
- Compare: Arm B: Daratumumab Hyaluronidase vs similar drugs
- Pricing: Arm B: Daratumumab Hyaluronidase cost, discount & access