Drug updated on 4/17/2024
| 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.
Summary
- Bortezomib (Velcade) is a reversible proteasome inhibitor indicated for adult patients with multiple myeloma and mantle cell lymphoma, showing potent antineoplastic activity by inhibiting increased proteasome activity in myeloma cells.
- The analysis of seven studies reveals that Bortezomib, when combined with lenalidomide, shows similar efficacy to Carfilzomib-based regimens in newly diagnosed multiple myeloma in terms of overall response rates and progression-free survival.
- In comparison to other drug combinations such as Ibrutinib plus bendamustine and rituximab for patients with mantle cell lymphoma ineligible for intensive therapy, Bortezomib-based combinations like VR-CAP showed less improvement in progression-free survival.
- When combined with monoclonal antibodies (MAbs), Bortezomib along with immunomodulatory drugs plus dexamethasone/prednisone demonstrated varied efficacy based on the target of MAbs; however, it showed longer PFS and better treatment response when combined specifically with CD38 MAbs.
- Bortezomib’s safety profile indicates risks associated with grade ≥3 neurologic symptoms, gastrointestinal symptoms, fatigue, particularly during consolidation/maintenance therapy settings. However, subcutaneous administration has shown significantly lower incidence of specific all-grade or grade 3-4 adverse events compared to intravenous administration.
- For various populations/subgroup considerations: Newly Diagnosed Multiple Myeloma patients show a high overall response rate from both Carfilzomib-based therapies as well as Bortezomib, indicating their potential role in early disease management, while elderly or newly diagnosed mantle cell lymphoma patients who are ineligible for intensive therapy might benefit more from Ibrutinib-based therapies compared to Bortezomib.
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 |