OnCo
drugsProductApproved2019🇪🇺🇬🇧🇯🇵🇨🇳🇦🇺

Polatuzumab vedotin

Polatuzumab vedotin is an ADC against CD79b that, swapped into the classic R-CHOP regimen, became the first improvement on frontline lymphoma therapy in twenty years.

POLARIX (2022): Pola-R-CHP versus R-CHOP in untreated DLBCL, IPI 2-5. Two-year PFS 76.7% vs 70.2% (HR 0.73); five-year PFS 64.9% vs 59.1% (HR 0.77) with OS HR 0.85, not significant. Approved US April 2023 for frontline DLBCL (IPI ≥2) and since 2019 with bendamustine-rituximab for relapsed disease. Peripheral neuropathy is the class toxicity.

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Payload: MMAE · 2D coordinates (no PubChem conformer)
PubChem
How it works, step by step · animated schematic, not to scale
Antibody-drug conjugate (ADC)
Mechanism, step by step
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1.Antibody binds CD79b on the B-cell receptor complex

Modality
ADC
Mechanism
Humanised anti-CD79b IgG1 internalised via the B-cell receptor complex; MMAE released by cathepsin B; bystander killing.
Brand / code
Polivy
Payload
MMAE (tubulin inhibitor), DAR ~3.5
Linker
mc-vc-PABC, protease-cleavable
Dosing & schedule
Route
IV
Schedule
1.8 mg/kg every 21 days for 6 cycles with R-CHP (frontline) or with BR (relapsed)
Dose modifications
Reduce to 1.4 mg/kg for grade 2-3 neuropathy; discontinue for grade 4
Monitoring
Neuropathy, neutropenia, infections, infusion reactions

Source: www.gene.com/download/pdf/polivy_prescribing.pdf. Doses are for orientation; the current label governs.

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.

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.

Assistance programmes

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Cancer Drugs FundNICE TA649 · 2020SMC: accepted
Appraised for
With bendamustine-rituximab for relapsed or refractory DLBCL not eligible for transplant
Notes
First-line pola-R-CHP for DLBCL (POLARIX) recommended in TA874 (2023).
Cancer Drugs Fund
Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA649 · NHS England Cancer Drugs Fund list · SMC advice: polatuzumab vedotin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 10 Jun 2019ApprovalUS

    Accelerated approval with BR in R/R DLBCL

  2. 19 Apr 2023ApprovalUS

    Frontline Pola-R-CHP (POLARIX)

Approvals

RegionYearIndication
US2019Relapsed/refractory DLBCL with bendamustine-rituximab after ≥2 lines (accelerated)
US2023Untreated DLBCL, IPI ≥2, with R-CHP (Pola-R-CHP)

Safety

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Toxicity profile
Adverse eventAny gradeGrade 3+
Peripheral neuropathy
52.9%
1.6%
Neutropenia
28.3%
Febrile neutropenia
13.8%
Diarrhoea
30.8%

POLARIX Pola-R-CHP arm. 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
86 studies31 recruiting78 Phase 28 Phase 3
Search “Polatuzumab vedotin” 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
Polatuzumab vedotin
intervention: Polatuzumab vedotin
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Key papers

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Latest papers

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Literature trend103 papers in the last 12 months+98% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Polatuzumab vedotin" OR ABSTRACT:"Polatuzumab vedotin" OR TITLE:"Polivy" OR ABSTRACT:"Polivy") 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 Polatuzumab vedotin, not a curated reading list.

Connected

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