Drug updated on 9/4/2024
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
Summary
- Darzalex (daratumumab) is 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 adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; 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; 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; in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; 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; 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; and 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.
- This summary is based on the review of 24 systematic reviews/meta-analyses. [1-23]
- CR/sCR Rate: Daratumumab-based regimens showed a significantly higher complete remission/stringent complete remission (CR/sCR) rate in transplant-ineligible newly diagnosed multiple myeloma (TIE-NDMM) compared to RVD/RVD-lite (47% vs. 24%, P<0.01).
- Progression-Free Survival (PFS): Daratumumab-based regimens significantly improved median PFS in TIE-NDMM compared to RVD/RVD-lite (52.6 months vs. 35.1 months, HR 0.77, 95% CI, 0.66-0.90) and in relapsed/refractory multiple myeloma (RRMM) when combined with other agents (HR 0.552, 95% CI 0.461-0.659).
- Overall Survival (OS): No significant difference in OS was observed between daratumumab-based regimens and RVD/RVD-lite in TIE-NDMM (HR 1.03, 95% CI 0.86-1.23), but daratumumab combinations improved OS in RRMM (HR 0.737, 95% CI 0.657-0.827).
- Efficacy in High-Risk Patients: Daratumumab improved PFS in both standard-risk and cytogenetically high-risk RRMM patients (HR 0.45, 95% CI 0.30-0.67) and in newly diagnosed high-risk multiple myeloma (HR 0.67, 95% CI 0.47-0.95).
- Daratumumab Combinations: Higher rates of hematologic and non-hematologic treatment-emergent adverse events (TEAEs), including thrombocytopenia, neutropenia, upper respiratory tract infection, pneumonia, bronchitis, dyspnea, diarrhea, pyrexia, back pain, arthralgia, fatigue, insomnia, and hypertension, were reported with daratumumab-based regimens.
- Specific Adverse Events: There was a significantly higher prevalence of grade 3 or higher neutropenia and pneumonia in patients receiving daratumumab.
- Discontinuation Rates: Daratumumab-based regimens showed lower treatment-related discontinuation rates compared to RVD/RVD-lite in transplant-ineligible newly diagnosed multiple myeloma (7% vs. 16%, P=0.03).
- Elderly and High-Risk Patients: Daratumumab-based regimens, including DaraLenDex, demonstrated high efficacy in elderly patients with relapsed/refractory multiple myeloma (R/R MM) and improved progression-free survival (PFS) in high-risk cytogenetics across both newly diagnosed and relapsed/refractory multiple myeloma (NDMM and RRMM).
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 |