BLAINJECTIONINJECTABLEPriority Review
Approved
Nov 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
DARZALEX (daratumumab) by Johnson & Johnson is cd38-directed antibody interactions [moa]. Approved for cd38-directed cytolytic antibody [epc]. First approved in 2015.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DARZALEX (daratumumab) is a CD38-directed monoclonal antibody approved in 2015 for multiple myeloma. It works by binding to CD38 on plasma cells and triggering cytolytic immune responses including ADCC, ADCP, and CDC. The drug has become a standard-of-care backbone in myeloma treatment across multiple lines of therapy.
$0.016BPart D
PeakAt peak lifecycle with moderate Part D claims volume; commercial team remains focused on maintenance and market defense against competitor encroachment.
Mechanism of Action
CD38-directed Antibody Interactions
Pharmacologic Class:
CD38-directed Cytolytic Antibody
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
Started Jul 2026
500 enrolled
Multiple Myeloma
A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL).
Started May 2026
30 enrolled
Multiple MyelomaAL Amyloidosis
A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
Started May 2026
270 enrolled
High Risk Smoldering Multiple Myeloma (HR-SMM)
ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma
Started Apr 2026
160 enrolled
Multiple MyelomaNewly Diagnosed Multiple MyelomaTransplant Ineligible+1 more
A Study to Compare the PK , Safety, and Immunogenicity of QL2109 With Daratumumab in Male Subjects
Started Mar 2026
102 enrolled
Multiple Myeloma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.