Daratumumab

(Darzalex®)

Darzalex®

Drug updated on 11/10/2023

Dosage FormInjection (intravenous; 120 mg daratumumab and 2,000 units hyaluronidase/mL)
Drug ClassCD38-directed cytolytic antibodies
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in combination with lenalidomide and dexamethasone for the treatment of adults newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant and in adults with relapsed or refractory multiple myeloma who have received at least one prior therapy.
  • Indicated in combination with bortezomib, melphalan and prednisone for the treatment of adult patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant.
  • Indicated in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant.
  • Indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
  • Indicated in combination with carfilzomib and dexamethasone in adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
  • Indicated in combination with pomalidomide and dexamethasone in adult patients with multiple myeloma who have received at least two prior lines of therapy including lenalidomide and a proteasome inhibitor.
  • Indicated as a monotherapy for adult patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI.

Product Monograph / Prescribing Information

Document TitleYearSource
Darzalex (daratumumab) Prescribing Information.2022Janssen Biotech, Inc., Horsham, PA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Relapsed and refractory multiple myeloma: A systematic review and network meta-analysis of the efficacy of novel therapies2023British journal of haematology
Daratumumab in combination for untreated multiple myeloma when a stem cell transplant is suitable.2022NICE
Clinical and pharmacoeconomic combined report.2022CADTH
Efficacy of maintenance treatment in patients with multiple myeloma: a systematic review and network meta-analysis.2022Hematology
Treatment Regimens for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: A Systematic Literature Review and Network Meta-analysis2022Advances in therapy
The efficacy and safety of triplet regimens based on pomalidomide and dexamethasone for treatment of relapsed/refractory multiple myeloma: a systematic review and meta-analysis2022European review for medical and pharmacological sciences
Anti B-cell maturation antigen CAR T-cell and antibody drug conjugate therapy for heavily pre-treated relapsed and refractory multiple myeloma. 2021ICER
Daratumumab provides a survival benefit in relapsed and refractory multiple myeloma, independent of baseline clinical characteristics: a meta-analysis. 2021Pharmacology Research and Perspectives
Treatment of lenalidomide exposed or refractory multiple myeloma: network meta-analysis of lenalidomide-sparing regimens. 2021Frontiers in Oncology
A systematic review and network meta-analysis of randomized data on efficacy of novel therapy combinations in patients with lenalidomide-refractory multiple myeloma. 2021Clinical Lymphoma, Myeloma & Leukemia
Efficacy and safety of daratumumab in the treatment of multiple myeloma: a systematic review and meta-analysis.2021Journal of International Medical Research
The role of novel agents for consolidation after autologous transplantation in newly diagnosed multiple myeloma: a systematic review. 2021Annals of Hematology
Treatment of relapsed/refractory multiple myeloma in the bortezomib and lenalidomide era: a systematic review and network meta-analysis. 2021Annals of Hematology
A systematic review and network meta-analysis of randomized data on efficacy of novel therapy combinations in patients with lenalidomide-refractory multiple myeloma. 2021Clinical Lymphoma, Myeloma & Leukemia
Daratumumab-based therapies in transplant-ineligible patients with untreated multiple myeloma and hepatic dysfunction: a systematic review of subgroup analyses. 2021Journal of Oncology Pharmacy Practice
Addition of daratumumab to multiple myeloma backbone regimens significantly improves clinical outcomes: a systematic review and meta-analysis of randomised controlled trials. 2021Scientific Reports
Efficacy and Safety of Daratumumab-based Regimens in Pretreated Light Chain (AL) Amyloidosis: A Systematic Review.2021Clinical Lymphoma, Myeloma & Leukemia
Final clinical guidance report: daratumumab (Darzalex) + Rd for newly diagnosed multiple myeloma. 2020CADTH
Relative efficacy of treatment options in transplant-ineligible newly diagnosed multiple myeloma: results from a systematic literature review and network meta-analysis2020Leukemia & lymphoma
Efficacy and safety of frontline regimens for older transplant-ineligible patients with multiple myeloma: A systematic review and meta-analysis2020Journal of geriatric oncology
Daratumumab with bortezomib and dexamethasone for previously treated multiple myeloma.2019NICE
Daratumumab added to standard of care in patients with newly diagnosed multiple myeloma: a network meta-analysis.2019European Journal of Haematology
Treatment outcomes in patients with newly diagnosed multiple myeloma who are ineligible for stem-cell transplantation: systematic review and network meta-analysis.2019Clinical Lymphoma, Myeloma & Leukemia
Final clinical guidance report daratumumab (Darzalex) +VMP for multiple myeloma.2019CADTH
A comparison of the efficacy of immunomodulatory-free regimens in relapsed or refractory multiple myeloma: a network meta-analysis2019Leukemia & lymphoma
Upfront treatment for newly diagnosed transplant-ineligible multiple myeloma patients: A systematic review and network meta-analysis of 14,533 patients over 29 randomized clinical trials2019Critical reviews in oncology/hematology
A Comparison of the efficacy of immunomodulatory-containing regimens in relapsed/refractory multiple myeloma: a network meta-analysis.2018Clinical Lymphoma, Myeloma & Leukemia
Comparative efficacy of treatments for previously treated multiple myeloma: a systematic literature review and network meta-analysis.2018Clinical Therapeutics
Systematic review and meta-analysis of the efficacy and safety of novel monoclonal antibodies for treatment of relapsed/refractory multiple myeloma2017Oncotarget
Systematic Literature Review and Network Meta-Analysis of Treatment Outcomes in Relapsed and/or Refractory Multiple Myeloma2017Journal of clinical oncology

Clinical Practice Guidelines