Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous or intravenous; 3.5 mg) |
Drug Class | Proteasome inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with multiple myeloma.
- Indicated for the treatment of adult patients with mantle cell lymphoma.
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Summary
- Velcade (bortezomib) is indicated for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma.
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Carfilzomib vs Bortezomib in NDMM: Carfilzomib-based regimens demonstrated a high Overall Response Rate (ORR) ranging from 80% to 100%, with Minimal Residual Disease (MRD) negativity achieved in 60% to 95% of patients; however, the ENDURANCE trial reported no superior progression-free survival (PFS) for carfilzomib-lenalidomide compared to bortezomib-lenalidomide.
- Monoclonal Antibodies with Bortezomib: CD38-targeting monoclonal antibodies showed improved PFS with hazard ratios of 0.662 (CD38 vs. SLAMF7), 0.317 (CD38 vs. PD-1/PD-L1), and 0.479 (SLAMF7 vs. PD-1/PD-L1), along with higher complete response (CR) rates (RR = 2.253) compared to SLAMF7.
- Bortezomib Dosing Schedules: Once-weekly bortezomib dosing provided comparable ORR to twice-weekly dosing (RR = 1.00) but with a reduced incidence of peripheral neuropathy, with relative risks of 0.48 for any grade and 0.21 for grade 3 or higher.
- Carfilzomib Regimens: Hematological toxicity was the most common adverse event, with non-hematological toxicity including cardiovascular issues and electrolyte disturbances.
- Monoclonal Antibodies (MAbs) + Bortezomib: The CD38 group had a higher incidence of grade 3 or higher neutropenia (RR = 1.818) compared to SLAMF7.
- Bortezomib-Based Consolidation and Maintenance: There was an increased risk of grade ≥3 adverse events, including neurologic and gastrointestinal symptoms, and fatigue.
- Subcutaneous (SC) vs. Intravenous (IV) Bortezomib: SC administration had a lower incidence of peripheral sensory neuropathy, leukopenia, and thrombocytopenia compared to IV administration.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Velcade (bortezomib) Prescribing Information. | 2022 | Takeda Pharmaceuticals America Inc., Lexington, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Clinical practice guideline multiple myeloma. | 2022 | Medical Scientific Advisory Group (MSAG) to Myeloma Australia (MA) |
Multiple myeloma, version 3.2021, NCCN clinical practice guidelines in oncology. | 2021 | Journal of the National Comprehensive Cancer Network |