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Bortezomib

Bortezomib was the first proteasome inhibitor: it jams the cell's protein-recycling machine, which antibody-factory plasma cells cannot tolerate.

Approved 2003 (relapsed), 2008 (frontline). Subcutaneous weekly dosing cut neuropathy from ~50% to ~30%. Part of VRd and Dara-VRd induction and of bortezomib-based regimens in mantle cell lymphoma and amyloidosis. Generic.

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Bortezomib · 2D coordinates (no PubChem conformer)
PubChem
Modality
Proteasome inhibitor
Mechanism
Reversible inhibitor of the 26S proteasome chymotrypsin-like site; unfolded-protein stress and NF-κB inhibition trigger plasma-cell apoptosis.
Brand / code
Velcade
Dosing & schedule
Route
Subcutaneous (preferred) or IV
Schedule
1.3 mg/m2 days 1, 4, 8, 11 (21-day) or weekly
Monitoring
Peripheral neuropathy, herpes zoster prophylaxis, thrombocytopenia
Medicare
Part B (clinician-administered)

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.

Commercial insurance
covered on label

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.

NICE recommendedNICE TA129 · 2007SMC: accepted
Appraised for
Multiple myeloma at first relapse
Notes
Untreated myeloma with thalidomide: TA228 (2011). Induction before transplant: TA311 (2014). Mantle cell lymphoma: TA370. Generic since 2019. TA129 introduced the first NHS response-based rebate scheme.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA129 · SMC advice: bortezomib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2003Relapsed myeloma (accelerated)
US2008Newly diagnosed myeloma

Safety

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Toxicity profile
Adverse eventAny gradeGrade 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.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
778 studies8 recruiting84 Phase 219 Phase 3
Search “Bortezomib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Bortezomib
intervention: Bortezomib
Open on ClinicalTrials.gov →

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Key papers

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rctNature Medicine 2025changed practice
CEPHEUS: daratumumab quadruplet for newly diagnosed myeloma patients not having a transplant, with MRD-negativity as the main endpoint

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.

rctNew England Journal of Medicine 2024changed practice
PERSEUS: daratumumab added to bortezomib-lenalidomide-dexamethasone around autologous transplant in newly diagnosed myeloma

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.

rctNew England Journal of Medicine 2023changed practice
CARTITUDE-4: cilta-cel CAR-T versus standard combinations after one to three prior lines of myeloma therapy

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.

Latest papers

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Literature trend555 papers in the last 12 months+2% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

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