Last reviewed · How we verify
Darzalex
At a glance
| Generic name | Darzalex |
|---|---|
| Also known as | Daratumumab, daratumumab |
| Sponsor | Shanghai Henlius Biotech |
| Target | Lymphocyte differentiation antigen CD38 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Multiple myeloma
- Systemic AL amyloidosis
Common side effects
- Peripheral neuropathy
- Fatigue
- Upper respiratory infection
- Constipation
- Musculoskeletal pain
- Insomnia
- Rash
- Diarrhea
- Edema
- Pyrexia
Serious adverse events
- Pneumonia
- COVID-19
- Thromboembolism
- Diarrhea
- Sepsis
- Fatal adverse reactions (CEPHEUS)
- Fatal adverse reactions (PERSEUS)
- Serious adverse reactions (CEPHEUS)
- Serious adverse reactions (PERSEUS)
Key clinical trials
- A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (PHASE3)
- Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma (PHASE3)
- Phase II Study of the CD38 Antibody Daratumumab in Patients With High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma (PHASE2)
- 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 Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant (PHASE3)
- A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma (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 CI brief — competitive landscape report
- Darzalex updates RSS · CI watch RSS
- Shanghai Henlius Biotech portfolio CI