Last reviewed 2026-05-13 · How we verify

Darzalex (daratumumab)

Daratumumab binds CD38 on tumor cells, inducing apoptosis and immune-mediated lysis via CDC, ADCC, and ADCP.

DARZALEX FASPRO is an IgG1κ monoclonal antibody targeting CD38 combined with hyaluronidase for subcutaneous administration in multiple myeloma and light chain amyloidosis. The drug demonstrates potent anti-tumor activity through direct apoptosis induction and multiple immune-mediated mechanisms including CDC, ADCC, and ADCP. Key risks include severe hypersensitivity reactions and interference with blood bank testing and disease monitoring assays requiring specialized mitigation strategies. The combination formulation offers improved convenience over intravenous daratumumab with comparable pharmacokinetic exposure across monotherapy and combination regimens.

At a glance

Mechanism of action

Daratumumab is an IgG1κ human monoclonal antibody that binds to CD38, a transmembrane glycoprotein (48 kDa) expressed on the surface of hematopoietic cells, including clonal plasma cells in multiple myeloma and light chain (AL) amyloidosis. The antibody inhibits growth of CD38-expressing tumor cells by inducing apoptosis directly through Fc-mediated cross-linking as well as by immune-mediated tumor cell lysis through complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). Additionally, a subset of myeloid-derived suppressor cells (CD38+MDSCs), regulatory T cells (CD38+Tregs), and B cells (CD38+Bregs) are decreased by daratumumab. DARZALEX FASPRO also contains hyaluronidase, an endoglycosidase that depolymerizes hyaluronan in the extracellular matrix, increasing subcutaneous tissue permeability locally and reversibly within 24 to 48 hours.

Approved indications

• Multiple myeloma
• Systemic AL amyloidosis

Common side effects

• Anaemia
• Neutropenia
• Thrombocytopenia
• Diarrhoea
• Fatigue
• Constipation
• Nausea
• Insomnia
• Asthenia
• Pyrexia
• Cough
• Bronchitis

Drug interactions

• Indirect Antiglobulin Tests (Indirect Coombs Test)
• Serum Protein Electrophoresis (SPE) and Immunofixation (IFE) Tests

Key clinical trials

• Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma (PHASE3)
• Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. (PHASE3)
• An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD (PHASE2)
• Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (PHASE3)
• Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma (PHASE2)
• A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma (PHASE3)
• A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma (PHASE1)
• A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma (PHASE3)

Primary sources

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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
• Johnson & Johnson portfolio CI