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Dara SC
Dara SC (daratumumab subcutaneous) is a monoclonal antibody that targets CD38 on multiple myeloma cells, triggering their destruction through multiple immune mechanisms.
Dara SC (daratumumab subcutaneous) is a monoclonal antibody that targets CD38 on multiple myeloma cells, triggering their destruction through multiple immune mechanisms. Used for Multiple myeloma (newly diagnosed and relapsed/refractory), Light chain myeloma.
At a glance
| Generic name | Dara SC |
|---|---|
| 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 binds to CD38, a surface antigen highly expressed on multiple myeloma cells, leading to cell death via antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC). The subcutaneous formulation provides improved convenience and tolerability compared to intravenous administration while maintaining 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
- Diarrhea
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 Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma (PHASE1, PHASE2)
- A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (PHASE3)
- Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure (EARLY_PHASE1)
- Rapid dFLC Response Predict CHR in AL Amyloidosis
- A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS) (PHASE2)
- Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |