Drug updated on 3/28/2024
| Dosage Form | Injection (intravenous; 120 mg daratumumab and 2,000 units hyaluronidase/mL) |
| Drug Class | CD38-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.
Summary
- Daratumumab (Darzalex) is indicated 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.
- A total of 23 systematic reviews/meta-analyses were reviewed to gather information about this drug's safety and effectiveness.
- When combined with lenalidomide and dexamethasone, daratumumab showed a significant reduction in risk of progression or death compared to other treatments, making it an effective choice for treating relapsed/refractory multiple myeloma.
- For patients newly diagnosed with multiple myeloma ineligible for autologous stem cell transplant, combinations including daratumumab proved highly effective in improving progression-free survival (PFS) and overall survival rates.
- In terms of maintenance therapy, combining lenalidomide with daratumumab significantly enhanced overall survival rates while prolonging PFS when compared to placebo alone.
- The use of Daratumumab was associated higher risks such as lymphopenia and infusion-related reactions indicating a need for careful monitoring during these therapies despite its efficacy benefits over other drugs used previously by the patient population under study.
- Across various subgroups like age, disease stage according International Staging System (ISS), type measurable MM & baseline renal function; Darzalex demonstrated consistent effectiveness suggesting broad applicability across different patient characteristics irrespective previous treatment exposure.
- Darzalex may lack benefit among patients suffering from hepatic dysfunction which suggests that individual health conditions should be considered before prescribing this medication even though it has shown superior outcomes when compared directly or indirectly via network meta-analysis against other therapies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Darzalex (daratumumab) Prescribing Information. | 2022 | Janssen Biotech, Inc., Horsham, PA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Multiple myeloma: EHA-ESMO clinical practice guidelines for diagnosis, treatment and follow-up. | 2021 | Annals of Oncology |