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.
1.Antibody binds CD79b on the B-cell receptor complex
- 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
- Genentech Access Solutions
- Genentech Patient Foundation — Free medicine for eligible patients regardless of insurance type.
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- 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.
- 10 Jun 2019ApprovalUS
Accelerated approval with BR in R/R DLBCL
- 19 Apr 2023ApprovalUS
Frontline Pola-R-CHP (POLARIX)
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2019 | Relapsed/refractory DLBCL with bendamustine-rituximab after ≥2 lines (accelerated) |
| US | 2023 | Untreated DLBCL, IPI ≥2, with R-CHP (Pola-R-CHP) |
| Adverse event | Any grade | Grade 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
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- IdeaTumour-on-a-chip with blood flow to test whether big drugs actually get in
Shares Bystander effect (ADC), Payload (ADC), Antibody-drug conjugate (ADC).
- TermMMAF
Shares Bystander effect (ADC), Payload (ADC), Antibody-drug conjugate (ADC).
- TermDM1
Shares Bystander effect (ADC), Payload (ADC), Antibody-drug conjugate (ADC).
- Key paperEPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T
Shares CD20 bispecific + CD79b ADC (mosunetuzumab + polatuzumab), Mosunetuzumab, Roche / Genentech, Diffuse large B-cell lymphoma.
- TermDM4
Shares Bystander effect (ADC), Payload (ADC), Antibody-drug conjugate (ADC).
- TermInternational Prognostic Index (IPI)
Shares POLARIX, Diffuse large B-cell lymphoma.
- IdeaUse antibodies to deliver protein-destroying drugs into the right cells
Shares Bystander effect (ADC), Payload (ADC), Antibody-drug conjugate (ADC).
- TermCell of origin (GCB vs ABC)
Shares CD79b, Diffuse large B-cell lymphoma.