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PMID
Authors
Title Velcade (Bortezomib) FDA Drug Label
Journal
Vol
Issue
Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021602
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Bortezomib Bortezomib 6 39
Drug Name Trade Name Synonyms Drug Classes Drug Description
Bortezomib Velcade Velcade (bortezomib) is a reversible proteasome inhibitor that inhibits survival of malignant cells and regulates bone remodeling (PMID: 26579531). Velcade (bortezomib) is FDA approved for the treatment of mantle cell lymphoma and multiple myeloma (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown multiple myeloma not applicable Bortezomib FDA approved Actionable In a Phase III trial that supported FDA approval, Velcade (bortezomib) treatment resulted in superior response rate (38% vs 18%, p<0.01), improved time to progression (6.22 vs 3.49 months, HR=0.55, p<0.001), and overall survival (HR=0.57, p=0.001) compared to dexamethasone in patients with relapsed multiple myeloma (PMID: 15958804; NCT00048230). detail... 15958804
Unknown unknown multiple myeloma not applicable Bortezomib FDA approved Actionable In a Phase III trial that supported FDA approval, addition of Velcade (bortezomib) to melphalan and prednisone combination therapy significantly improved time to progression (24.0 vs 16.6 months, HR=0.48, p<0.001) in patients with newly diagnosed multiple myeloma, with improved partial response rate (71% vs 35%) and complete response rate (30% vs 4%), and prolonged overall survival (HR=0.61, p=0.008) (PMID: 18753647; NCT00111319). detail... 18753647
Unknown unknown mantle cell lymphoma not applicable Bortezomib FDA approved Actionable In a Phase II trial (PINNACLE) that supported FDA approval, Velcade (bortezomib) monotherapy resulted in an overall response rate of 31% (48/155, 12 complete response, 36 partial response) in patients with relapsed or refractory mantle cell lymphoma, with a median overall survival not reached after a median follow-up of 13.4 months (PMID: 17001068; NCT00063713). 17001068 detail...
Unknown unknown mantle cell lymphoma not applicable Bortezomib FDA approved Actionable In a Phase III trial that supported FDA approval, substituting Velcade (bortezomib) for vincristine in R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) resulted in improved progression-free survival (24.7 vs 14.4 months, HR=0.63, p<0.001) compared to R-CHOP in patients with newly diagnosed mantle cell lymphoma (PMID: 25738670; NCT00722137). 25738670 detail...