Bortezomib

(Velcade®)

Bortezomib

Drug updated on 9/4/2024

Dosage FormInjection (subcutaneous or intravenous; 3.5 mg)
Drug ClassProteasome 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
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  • 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 TitleYearSource
Velcade (bortezomib) Prescribing Information.2022Takeda Pharmaceuticals America Inc., Lexington, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Clinical practice guideline multiple myeloma.2022Medical Scientific Advisory Group (MSAG) to Myeloma Australia (MA)
Multiple myeloma, version 3.2021, NCCN clinical practice guidelines in oncology.2021Journal of the National Comprehensive Cancer Network