# Daratumumab

Source: https://onco.cc/drugs/daratumumab/  
OnCo record `daratumumab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The CD38 antibody that turned triplets into quadruplets: adding it to standard induction roughly halves the risk of myeloma progressing.

## Summary

First approved 2015 (monotherapy after ≥3 lines); now in frontline quadruplets: Dara-VRd (PERSEUS, transplant-eligible; CEPHEUS, transplant-ineligible), Dara-Rd (MAIA, OS benefit), Dara-VMP (ALCYONE). Subcutaneous Faspro (2020) gives a 5-minute injection. Approved in high-risk smouldering myeloma (AQUILA, 2025-26) and with teclistamab (MajesTEC-3, March 2026). Also used in AL amyloidosis. J&J/Genmab.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Darzalex / Darzalex Faspro (SC)
- Modality: Monoclonal antibody (anti-CD38)
- Mechanism: Human IgG1κ anti-CD38: CDC, ADCC, ADCP, apoptosis via Fc crosslinking, and depletion of CD38+ regulatory T and B cells.
- Approvals: US 2015: Relapsed myeloma after ≥3 lines; US 2019: Newly diagnosed, transplant-ineligible with Rd (MAIA) and VMP; US 2024: Newly diagnosed transplant-eligible with VRd (PERSEUS); US 2026: With teclistamab after ≥1 line (MajesTEC-3); high-risk smouldering myeloma (AQUILA)
- Dosing: Subcutaneous 1,800 mg (or IV 16 mg/kg); Weekly × 8, every 2 weeks × 8, then every 4 weeks
- Toxicity (grade 3+): Infusion/injection reaction 1%; Neutropenia (with Rd) 50%; Pneumonia 14%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Daratumumab
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Daratumumab

## Connected records

- cancers: [HIV-associated (AIDS-related) lymphomas](https://onco.cc/cancers/hiv-associated-lymphoma/), [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Newly diagnosed multiple myeloma, transplant-eligible](https://onco.cc/cancers/myeloma-transplant-eligible/), [Newly diagnosed multiple myeloma, transplant-ineligible](https://onco.cc/cancers/myeloma-transplant-ineligible/), [Plasma cell leukaemia](https://onco.cc/cancers/plasma-cell-leukaemia/), [Relapsed or refractory multiple myeloma](https://onco.cc/cancers/myeloma-relapsed-refractory/), [Smouldering multiple myeloma](https://onco.cc/cancers/smouldering-myeloma/)
- technologies: [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [CD38](https://onco.cc/targets/cd38/)
- companies: [Genmab](https://onco.cc/companies/genmab/), [Halozyme Therapeutics](https://onco.cc/companies/halozyme/), [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- terms: [ADCC (antibody-dependent cellular cytotoxicity)](https://onco.cc/terms/adcc/), [Infusion reactions, hypersensitivity and extravasation](https://onco.cc/terms/extravasation-infusion-reaction/), [M-protein, immunofixation and serum free light chains](https://onco.cc/terms/m-protein-free-light-chains/), [Smouldering myeloma / MGUS](https://onco.cc/terms/smoldering-myeloma/), [VRd and Dara-VRd (myeloma induction regimens)](https://onco.cc/terms/vrd/)
- trials: [A Modular, Phase I/II, Multicentre Study to Evaluate AZD4045, in Participants With Relapsed or Refractory Multiple Myeloma](https://onco.cc/trials/nct07681596/), [A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Darat](https://onco.cc/trials/nct04973605/), [A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)](https://onco.cc/trials/nct06464991/), [A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Rela](https://onco.cc/trials/nct07391657/), [A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination Wi](https://onco.cc/trials/nct05455320/), [A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethas](https://onco.cc/trials/nct06679101/), [A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractor](https://onco.cc/trials/nct03314181/), [A Study of Daratumumab](https://onco.cc/trials/nct05438043/), [A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Ind](https://onco.cc/trials/nct06577025/), [A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Mul](https://onco.cc/trials/nct04133636/), [A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal](https://onco.cc/trials/nct05552222/), [A Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma (AMMADINA)](https://onco.cc/trials/nct07742215/), [A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lena](https://onco.cc/trials/nct07095452/), [A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and/or Oral Antimyeloma ](https://onco.cc/trials/nct06953960/), [A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving T Cell Engaging Bi/Tri-spe](https://onco.cc/trials/nct06892522/), [A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)](https://onco.cc/trials/nct07393282/), [A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone](https://onco.cc/trials/nct06952478/), [A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple](https://onco.cc/trials/nct02773030/), [A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Tre](https://onco.cc/trials/nct03989414/), [A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide](https://onco.cc/trials/nct05623020/), [A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments](https://onco.cc/trials/nct05020236/), [AQUILA](https://onco.cc/trials/aquila/), [CARTITUDE-6](https://onco.cc/trials/cartitude-6/), [CASSIOPEIA](https://onco.cc/trials/cassiopeia/), [CEPHEUS](https://onco.cc/trials/cepheus/), [China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexame](https://onco.cc/trials/nct06868654/), [DRAMMATIC](https://onco.cc/trials/drammatic/), [IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers](https://onco.cc/trials/nct06119685/), [Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dex](https://onco.cc/trials/nct06868667/), [MAIA](https://onco.cc/trials/maia/), [MajesTEC-3](https://onco.cc/trials/majestec-3/), [Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants ](https://onco.cc/trials/nct04975997/), [PERSEUS](https://onco.cc/trials/perseus/), [Selinexor and Backbone Treatments of Multiple Myeloma Patients](https://onco.cc/trials/nct02343042/), [Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT](https://onco.cc/trials/nct07764978/), [Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma](https://onco.cc/trials/nct04649060/), [Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma](https://onco.cc/trials/nct04782687/)
- key papers: [AQUILA: daratumumab versus active monitoring in high-risk smouldering multiple myeloma](https://onco.cc/key-papers/paper-aquila-daratumumab-smouldering-nejm-2025/), [CARTITUDE-4: cilta-cel CAR-T versus standard combinations after one to three prior lines of myeloma therapy](https://onco.cc/key-papers/paper-cartitude-4-cilta-cel-nejm-2023/), [CASSIOPEIA: daratumumab added to bortezomib, thalidomide and dexamethasone before and after transplant in newly diagnosed myeloma](https://onco.cc/key-papers/paper-cassiopeia-lancet-2019/), [CEPHEUS: daratumumab quadruplet for newly diagnosed myeloma patients not having a transplant, with MRD-negativity as the main endpoint](https://onco.cc/key-papers/paper-cepheus-dara-vrd-natmed-2025/), [MAIA: adding daratumumab to lenalidomide-dexamethasone for older patients with newly diagnosed myeloma who cannot have a transplant](https://onco.cc/key-papers/paper-maia-daratumumab-rd-nejm-2019/), [PERSEUS: daratumumab added to bortezomib-lenalidomide-dexamethasone around autologous transplant in newly diagnosed myeloma](https://onco.cc/key-papers/paper-perseus-dara-vrd-transplant-nejm-2024/)
- pairings: [CD38 antibody added to PI-IMiD-dex (quadruplet induction)](https://onco.cc/pairings/cd38-plus-triplet/)
- ideas: [MRD-guided treatment-free intervals in myeloma](https://onco.cc/ideas/idea-mrd-guided-stop-myeloma/)
- people: [Saad Z. Usmani](https://onco.cc/people/saad-usmani/)
- institutions: [Winship Cancer Institute of Emory University](https://onco.cc/institutions/emory-winship/)
- pathways: [Complement in cancer](https://onco.cc/pathways/complement-in-cancer/), [NK-cell recognition: missing self & stress ligands](https://onco.cc/pathways/nk-cell-recognition/)
- biomarkers: [CD38 expression](https://onco.cc/biomarkers/cd38-expression/)

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