BLAINJECTIONINJECTABLE
Approved
May 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
7/8 — Comprehensive
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 36m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DARZALEX FASPRO is a CD38-directed monoclonal antibody combined with recombinant human hyaluronidase designed for subcutaneous administration, enabling faster infusion than intravenous formulations. It treats multiple myeloma and other CD38-expressing hematologic malignancies by triggering immune-mediated cytolysis of cancer cells. The hyaluronidase component enhances subcutaneous bioavailability and reduces administration time, improving patient convenience and clinical workflow.
$0.070BPart D
PeakStable
Peak-stage product with $70M Part D spending signals a mature, well-established commercial organization requiring cross-functional expertise in market maintenance and competitor defense.
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.