Daratumumab

(Darzalex®)

Darzalex®

Drug updated on 6/25/2024

Dosage FormInjection (intravenous; 100 mg/5 mL, 400 mg/20 mL)
Drug ClassMonoclonal antibodies
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in combination with lenalidomide and dexamethasone for the treatment of adults newly diagnosed adult patients with multiple myeloma who are ineligible for autologous stem cell transplant and in adult patients 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 and an immunomodulatory agent.

Latest News

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Summary
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  • Daratumumab (Darzalex) is indicated for the treatment of adults with multiple myeloma, both newly diagnosed and relapsed or refractory. It may be used alone or in combination with other drugs such as lenalidomide, dexamethasone, bortezomib, melphalan, prednisone, thalidomide, and carfilzomib.
  • Information was derived from 23 systematic reviews/meta-analyses focusing on daratumumab's safety and efficacy in treating multiple myeloma across different patient populations.
  • Compared to regimens like lenalidomide/bortezomib/dexamethasone (RVD), daratumumab shows superior efficacy, especially in terms of stringent complete remission rates and progression-free survival among transplant-ineligible newly diagnosed patients.
  • For elderly patients with relapsed/refractory multiple myeloma, adding daratumumab to their therapy has shown high effectiveness, particularly when combined with lenalidomide and dexamethasone. This combination has also demonstrated acceptable safety levels despite an increase in certain adverse events such as thrombocytopenia and neutropenia.
  • Various subgroups, including elderly patients, standard-risk cytogenetics patients, high-risk cytogenetics patients, those ineligible for transplant, or those who are refractory to lenalidomide-based treatments, have all benefited significantly from daratumumab-containing regimens.
  • Patients suffering from hepatic disease may potentially benefit from using this drug without significant differences in its efficacy based on hepatic function subgroup considerations.
  • Daratumumab combinations are frequently cited as most effective compared to other treatments, specifically DaraLenDex & DVMP regimens, which provide superior progression-free survival and overall survival benefits, vastly for relapsed/refractory multiple myeloma and newly diagnosed multiple myeloma respectively.
  • The use of daratumumab-containing regimens, especially when combined with lenalidomide-carfilzomib or daratumumab alone, has shown significant efficacy over placebo in extending progression-free survival post-induction therapy for newly diagnosed multiple myeloma.

Product Monograph / Prescribing Information

Document TitleYearSource
Darzalex (daratumumab) Prescribing Information.2023Janssen Biotech, Inc., Horsham, PA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Daratumumab-based immunotherapy vs. lenalidomide, bortezomib and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: a systemic review.2024Frontiers in Oncology
Progression-free survival efficacy in refractory/relapsed multiple myeloma among elderly patients: a systematic review.2023Life (Basel)
Efficacy and safety of anti-CD38 monoclonal antibodies in patients with relapsed/refractory multiple myeloma: a systematic review and meta-analysis with trial sequential analysis of randomized controlled trials.2023Frontiers in Oncology
Relapsed and refractory multiple myeloma: a systematic review and network meta-analysis of the efficacy of novel therapies.2023British Journal of Haematology
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-analysis.2022Advances 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-analysis.2022European Review for Medical and Pharmacological Sciences
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
Daratumumab provides a survival benefit in relapsed and refractory multiple myeloma, independent of baseline clinical characteristics: a meta-analysis.2021Pharmacology Research and Perspectives
Addition of daratumumab to multiple myeloma backbone regimens significantly improves clinical outcomes: a systematic review and meta-analysis of randomised controlled trials. 2021Scientific Reports
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
Daratumumab-based induction therapy for multiple myeloma: a systematic review and meta-analysis.2021Critical Reviews in Oncology/Hematology
Efficacy and safety of frontline regimens for older transplant-ineligible patients with multiple myeloma: a systematic review and meta-analysis.2020Journal of geriatric oncology
Relative efficacy of treatment options in transplant-ineligible newly diagnosed multiple myeloma: results from a systematic literature review and network meta-analysis.2020Leukemia & Lymphoma
Evaluation of daratumumab for the treatment of multiple myeloma in patients with high-risk cytogenetic factors.2020JAMA Oncology
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
A comparison of the efficacy of immunomodulatory-free regimens in relapsed or refractory multiple myeloma: a network meta-analysis.2019Leukemia & 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 trials.2019Critical Reviews in Oncology/Hematology

Clinical Practice Guidelines