Last reviewed · How we verify
Darzalex Faspro(Daratumumab)
Darzalex Faspro(Daratumumab) is a Monoclonal antibody (CD38-targeting) Biologic drug developed by Celltrion. It is currently in Phase 3 development for Multiple myeloma (newly diagnosed and relapsed/refractory), Light chain multiple myeloma.
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 and relapsed/refractory), Light chain multiple myeloma.
At a glance
| Generic name | Darzalex Faspro(Daratumumab) |
|---|---|
| Sponsor | Celltrion |
| Drug class | Monoclonal antibody (CD38-targeting) |
| Target | CD38 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Daratumumab targets CD38, a surface antigen highly expressed on multiple myeloma cells. Upon binding, it induces cell death through antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC). Darzalex Faspro is a subcutaneous formulation designed for faster administration compared to intravenous daratumumab.
Approved indications
- Multiple myeloma (newly diagnosed and relapsed/refractory)
- Light chain multiple myeloma
Common side effects
- Infusion reactions
- Neutropenia
- Anemia
- Thrombocytopenia
- Upper respiratory tract infection
- 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)
- A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments (PHASE3)
- A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma (PHASE1, PHASE2)
- Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing (PHASE2)
- 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)
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:
- Darzalex Faspro(Daratumumab) CI brief — competitive landscape report
- Darzalex Faspro(Daratumumab) updates RSS · CI watch RSS
- Celltrion portfolio CI
Frequently asked questions about Darzalex Faspro(Daratumumab)
What is Darzalex Faspro(Daratumumab)?
How does Darzalex Faspro(Daratumumab) work?
What is Darzalex Faspro(Daratumumab) used for?
Who makes Darzalex Faspro(Daratumumab)?
What drug class is Darzalex Faspro(Daratumumab) in?
What development phase is Darzalex Faspro(Daratumumab) in?
What are the side effects of Darzalex Faspro(Daratumumab)?
What does Darzalex Faspro(Daratumumab) target?
Related
- Drug class: All Monoclonal antibody (CD38-targeting) drugs
- Target: All drugs targeting CD38
- Manufacturer: Celltrion — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Multiple myeloma (newly diagnosed and relapsed/refractory)
- Indication: Drugs for Light chain multiple myeloma