Drug updated on 7/24/2024
Dosage Form | Injection (intravenous; 100 mg/5 mL, 400 mg/20 mL) |
Drug Class | Monoclonal 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
- 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 Title | Year | Source |
---|---|---|
Darzalex (daratumumab) Prescribing Information. | 2023 | Janssen Biotech, Inc., Horsham, PA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Multiple myeloma, version 2.2024, NCCN clinical practice guidelines in oncology. | 2023 | Journal of the NCCN |
Clinical practice guideline multiple myeloma. | 2022 | Myeloma Australia |
Practical considerations for the daratumumab management in Portuguese routine clinical practice: recommendations from an expert panel of hematologists. | 2021 | Frontiers in Oncology |
Multiple myeloma: EHA-ESMO clinical practice guidelines for diagnosis, treatment and follow-up. | 2021 | Annals of Oncology |
Treatment of multiple myeloma: ASCO and CCO joint clinical practice guideline. | 2019 | Journal of Clinical Oncology |