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Daratumumab Hyaluronidase-fihj
Daratumumab binds to CD38 on multiple myeloma cells to trigger their destruction, while hyaluronidase enables faster subcutaneous administration by breaking down hyaluronic acid in tissue.
Daratumumab binds to CD38 on multiple myeloma cells to trigger their destruction, while hyaluronidase enables faster subcutaneous administration by breaking down hyaluronic acid in tissue. Used for Multiple myeloma (newly diagnosed and relapsed/refractory), Light chain myeloma.
At a glance
| Generic name | Daratumumab Hyaluronidase-fihj |
|---|---|
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Drug class | CD38-targeting monoclonal antibody |
| Target | CD38 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Daratumumab is a monoclonal antibody that targets CD38, a surface antigen highly expressed on multiple myeloma cells, leading to cell death through antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and antibody-dependent cellular phagocytosis (ADCP). The addition of hyaluronidase (fihj) allows for subcutaneous injection with rapid absorption, improving patient convenience compared to intravenous administration while maintaining the same mechanism of action.
Approved indications
- Multiple myeloma (newly diagnosed and relapsed/refractory)
- Light chain myeloma
Common side effects
- Infusion reactions
- Infection
- Anemia
- Thrombocytopenia
- Fatigue
- Neuropathy
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)
- Daratumumab in STK11 Mutated NSCLC (PHASE2)
- Optimize First-line Treatment for AL Amyloidosis With t (11; 14) (NA)
- 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)
- ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma (PHASE2)
- Home Based Daratumumab Administration for Patients With Multiple Myeloma (PHASE4)
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 Hyaluronidase-fihj CI brief — competitive landscape report
- Daratumumab Hyaluronidase-fihj updates RSS · CI watch RSS
- Memorial Sloan Kettering Cancer Center portfolio CI