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Oncology · FDA Approved

Bortezomib (Velcade)

FDA-approved

Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

A dipeptidyl boronic acid that selectively and reversibly inhibits the 26S proteasome, disrupting the ubiquitin-proteasome pathway that degrades many intracellular proteins. Its anticancer effect is attributed mainly to inhibition of NF-kB pathway components involved in cell proliferation, survival and angiogenesis (PMID 30993606).

It was the first-in-class proteasome inhibitor and received accelerated FDA approval in 2003 for relapsed or refractory multiple myeloma (PMID 30993606).

02 · Research summary & key findings

FDA-approved for multiple myeloma (including previously untreated disease since 2008) and mantle cell lymphoma (PMID 30993606). The APEX trial showed higher response rates (38% vs. 18%), longer time to progression and better one-year survival with bortezomib than high-dose dexamethasone in relapsed myeloma (Richardson et al., NEJM, 2005) (PMID 15958804). The VISTA trial found that adding bortezomib to melphalan-prednisone extended time to progression (24.0 vs. 16.6 months) and improved overall survival in transplant-ineligible patients (PMID 18753647). Peripheral neuropathy was significantly less common with subcutaneous than intravenous administration, with similar efficacy (PMID 21507715).

03 · Regulatory status

Bortezomib (Velcade) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Bortezomib (Velcade) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.

04 · Administration routes

  • Subcutaneous injection
  • Intravenous

References

  1. [1]Bortezomib or high-dose dexamethasone for relapsed multiple myeloma N Engl J Med, 2005. PMID 15958804
  2. [2]Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma N Engl J Med, 2008. PMID 18753647
  3. [3]Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study Lancet Oncol, 2011. PMID 21507715
  4. [4]Bortezomib for the Treatment of Hematologic Malignancies: 15 Years Later Drugs R D, 2019. PMID 30993606

Primary literature

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