BLAINJECTIONINJECTABLE
Approved
May 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
6/8 — Strong
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj (human recombinant)) by Johnson & Johnson is cd38-directed antibody interactions [moa]. Approved for cd38-directed cytolytic antibody [epc]. First approved in 2020.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DARZALEX FASPRO is a subcutaneous formulation combining daratumumab (an anti-CD38 monoclonal antibody) with human recombinant hyaluronidase to enable rapid, at-home or clinic-based administration. It works by directing immune-mediated cytolysis against CD38-expressing cells, primarily used in hematologic malignancies. The hyaluronidase component facilitates subcutaneous delivery, reducing infusion time from hours to minutes compared to intravenous alternatives.
$0.070BPart D
PeakAt peak lifecycle with $70M in Part D spending, DARZALEX FASPRO supports mid-sized commercial teams focused on maintaining market penetration and driving patient access initiatives.
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 (4)
A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma
Started Aug 2025
486 enrolled
Refractory or Relapsed Multiple Myeloma
To Evaluate the Efficacy and Safety of QL2109 and DARZALEX FASPRO® in Multiple Myeloma
Started Jan 2025
284 enrolled
Multiple Myeloma
Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
Started Sep 2024
8 enrolled
Hematologic MalignancyBone Marrow Transplant RejectionAcute Myeloid Leukemia (AML)+9 more
A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults
Started Apr 2024
228 enrolled
Tumor
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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.