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Bortezomib was the first proteasome inhibitor: it jams the cell's protein-recycling machine, which antibody-factory plasma cells cannot tolerate.
Bortezomib is a reversible inhibitor of the chymotrypsin-like site of the 26S proteasome; the resulting unfolded-protein stress and NF-kappaB inhibition trigger apoptosis in plasma cells, which produce huge amounts of antibody and cannot tolerate a jammed protein-recycling system. It was the first proteasome inhibitor, approved in 2003 for relapsed myeloma and in 2008 for newly diagnosed disease. Subcutaneous weekly dosing cut peripheral neuropathy from around 50% to around 30% and is now preferred over intravenous twice-weekly schedules. It is part of VRd and Dara-VRd induction and of bortezomib-based regimens in mantle cell lymphoma and amyloidosis, and it is now generic. Thrombocytopenia and herpes zoster reactivation, which needs prophylaxis, are the other main issues. Bortezomib made proteasome inhibition a pillar of myeloma treatment and remains in most frontline regimens.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
Reversible inhibitor of the 26S proteasome chymotrypsin-like site; unfolded-protein stress and NF-κB inhibition trigger plasma-cell apoptosis.
1.Bortezomib slips into a pocket on its target.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Subcutaneous or IV in the clinic; HCPCS J9041. Generic bortezomib since 2022.
Multi-source generic; covered under the medical benefit without prior authorisation in most plans, as part of standard regimens. Prior authorisation is uncommon now that generics exist.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA129 · SMC advice: bortezomib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Multiple myeloma patients who received at least two prior therapies and demontrated disease progression on the last therapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Multiple myeloma patients who received at least two prior therapies and demontrated disease progression on the last therapy
Confirmed: the accelerated approval of 2003 converted to traditional approval 1.9 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 2003 | Relapsed myeloma (accelerated) |
| US | 2008 | Newly diagnosed myeloma |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Peripheral neuropathy | 38% | 6% |
| Thrombocytopenia | - | 30% |
subcutaneous (MMY-3021). Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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CEPHEUS extends the quadruplet standard to patients who are not going to transplant, closing the gap between transplant-eligible and ineligible populations. It is also one of the first phase 3 trials to be designed around MRD-negativity as the primary endpoint, which could shorten future myeloma trials by years. Frailer patients still need dose-adapted approaches.
PERSEUS, with the earlier GRIFFIN and CASSIOPEIA trials, made a four-drug daratumumab quadruplet the standard for fit patients heading to transplant. It also introduced MRD-directed stopping of the antibody, a step towards treatment that is deep but not indefinite. Whether transplant itself remains necessary on top of a quadruplet is now the open question.
CARTITUDE-4 is the first randomised trial to show that a CAR-T improves survival in myeloma, and it moved cilta-cel into second-line use (FDA approval 2024). For patients whose disease returns after first-line lenalidomide, a one-off cell therapy now competes with continuous drug combinations. Capacity, cost and the need for bridging therapy still limit who actually receives it.
Prophylactic cranial radiotherapy can be limited to central nervous system involvement and the highest-risk patients in childhood T-ALL, and bortezomib is a reasonable addition for T-lymphoblastic lymphoma.
Bortezomib should not be added to standard chemotherapy for childhood acute myeloid leukaemia; the trial's FLT3-ITD sorafenib cohorts were reported separately.
Quadruplet induction with a CD38 antibody became the standard for transplant-eligible patients in Europe. PERSEUS later did the same with the lenalidomide-based backbone used elsewhere.
Upfront transplant remains standard for fit patients because it lengthens the first remission, but deferring it to first relapse is a reasonable choice for some, particularly with deeper modern induction.
Bortezomib-based induction with early transplant consolidation became the accepted approach for fit patients with this rare aggressive disease; daratumumab-containing quadruplets are now added by extrapolation.
Query for this drug: (TITLE:"Bortezomib" OR ABSTRACT:"Bortezomib" OR TITLE:"Velcade" OR ABSTRACT:"Velcade") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Bortezomib, not a curated reading list.
Shares A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Mul, CASSIOPEIA: daratumumab added to bortezomib, thalidomide and dexamethasone before and after transplant in newly diagnosed myeloma, A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Rela, A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple.
Shares IFM 2006 prospective trial: bortezomib-based induction and transplantation for primary plasma cell leukaemia, A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Mul, Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma, CASSIOPEIA: daratumumab added to bortezomib, thalidomide and dexamethasone before and after transplant in newly diagnosed myeloma.
Shares Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma, A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Rela, A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Mult, Selinexor and Backbone Treatments of Multiple Myeloma Patients.
Shares Sundar Jagannath, Proteasome (PSMB5), Aaron Ciechanover, A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Rela.
Shares Kenneth C. Anderson, A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Mul, Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma, IFM 2009: lenalidomide, bortezomib and dexamethasone with or without upfront transplantation for myeloma.
Shares A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refrac, A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractor, A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Re, All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myelo.
Shares Avram Hershko, Aaron Ciechanover, Technion, Israel Institute of Technology, A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple.
Shares Sundar Jagannath, A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortez, A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With, A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Ind.