Drugs / Polatuzumab Vedotin
Polatuzumab Vedotin
also known as
pola · ACD-79B-VCMMAE · Anti-cd79b adc · DCDS-4501A · FCU-2711 · polatuzumab · Polatuzumab vedotin piiq · Polatuzumab vedotina · +4 more
Other / unclassified targets CD79B via depletion
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Polivy | — | 2020-01-16 | europa.eu ↗ |
Trials 74 · started per year
today
EU approved 2020
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Also used as a comparator or background therapy in 16 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07714421 Background | Dec 2026 → Oct 2030 expected | high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma | Jonsson Comprehensive Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06730542 Background | Apr 2025 → Apr 2030 expected | central nervous system cancer | Juan P. Alderuccio, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT04790903 Background | Jul 2021 → May 2024 | diffuse large B-cell lymphoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1 | NCT04323956 Comparator | Jun 2020 → Oct 2023 overdue | diffuse large B-cell lymphoma, high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement, marginal zone lymphoma | Mayo Clinic | Active not recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07638787 Background | Jun 2026 → Sep 2027 expected | large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT04882163 Background | Oct 2021 → Apr 2026 | B-cell non-Hodgkin lymphoma | Celgene Corporation | Withdrawn | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT07654426 Background | Oct 2026 → Dec 2030 expected | chemotherapy-induced toxicity, diffuse large B-cell lymphoma | Beth Israel Deaconess Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07677813 Background | Jun 2026 → Dec 2029 expected | MCD diffuse large B-cell lymphoma | Ou Bai, MD/PHD | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07594899 Background | May 2026 → May 2029 expected | large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07680933 Background | Mar 2026 → Jun 2027 expected | diffuse large B-cell lymphoma | The Affiliated Hospital of Xuzhou Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT07034508 Background | Jun 2025 → Dec 2027 expected | diffuse large B-cell lymphoma | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06890884 Comparator | Apr 2025 → Dec 2027 expected | diffuse large B-cell lymphoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06803693 Background | Apr 2025 → Apr 2028 expected | diffuse large B-cell lymphoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06441097 Background | Dec 2024 → Dec 2027 expected | diffuse large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04844866 Comparator | Aug 2021 → Jan 2025 overdue | diffuse large B-cell lymphoma | Miltenyi Biomedicine GmbH | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06047080 Background | Sep 2023 → Oct 2027 expected | large B-cell lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
Press releases naming this drug 16 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-18 | Roche Global Development | FDA accepts supplemental Biologics License Application for Roche’s Lunsumio and Polivy combination for people with relapsed or refractory large B-cell lymphoma roche.com ↗ |
| 2025-06-20 | Roche Global Development | Roche’s Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma roche.com ↗ |
| 2024-12-08 | Roche Global Development | Five-year results confirm Roche’s Polivy combination therapy as new standard of care for previously untreated aggressive lymphoma roche.com ↗ |
| 2023-04-19 | Roche Global Development | [Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche’s Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma roche.com ↗ |
| 2023-03-09 | Roche Global Development | FDA Advisory Committee votes in favour of the clinical benefit of Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma roche.com ↗ |
| 2022-12-12 | Roche Global Development | Roche presents new and updated data for Polivy in previously untreated diffuse large B-cell lymphoma at ASH 2022 roche.com ↗ |
| 2022-08-16 | Roche Global Development | FDA accepts supplemental Biologics License Application for Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma roche.com ↗ |
| 2022-05-25 | Roche Global Development | Roche’s Polivy combination approved by European Commission for people with previously untreated diffuse large B-cell lymphoma roche.com ↗ |
| 2022-03-25 | Roche Global Development | CHMP recommends EU approval of Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma roche.com ↗ |
| 2021-12-14 | Roche Global Development | Roche’s Polivy combination reduced the risk of disease worsening or death by 27% in people with previously untreated aggressive form of lymphoma roche.com ↗ |
| 2021-08-09 | Roche Global Development | [Ad hoc announcement pursuant to Art. 53 LR] Phase III study shows Roche's Polivy plus R-CHP is the first regimen in 20 years to significantly improve outcomes in previously untreated aggressive form of lymphoma compared to standard of care roche.com ↗ |
| 2020-12-07 | Roche Global Development | New data presented at ASH 2020 reinforces the benefit/risk profile of fixed-duration Polivy plus bendamustine and MabThera/Rituxan in patients with relapsed or refractory diffuse large B-cell lymphoma roche.com ↗ |
| 2020-01-21 | Roche Global Development | European Commission approves Roche’s Polivy for people with previously treated aggressive lymphoma roche.com ↗ |
| 2019-11-15 | Roche Global Development | CHMP recommends conditional EU approval of Roche’s Polivy for people with previously treated aggressive lymphoma roche.com ↗ |
| 2019-06-11 | Roche Global Development | FDA grants Roche’s Polivy accelerated approval for people with previously treated aggressive lymphoma roche.com ↗ |
| 2018-12-03 | Roche Global Development | Longer-term follow-up data demonstrate sustained benefit of polatuzumab vedotin-based treatment in relapsed or refractory diffuse large B-cell lymphoma roche.com ↗ |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 94 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Polatuzumab vedotin | “polatuzumab vedotin x1; dexamethasone x 5; vincristine x1, cyclophosphamide x 3; doxorubicin x1; methotrexate x; rituximab 2x; ITT x1” NCT05253495 ↗89“Polatuzumab vedotin will be administered at a dose of 1.8 mg/kg i.v. on day 2 of cycle 1, then on day 1 of each subsequent cycle.” NCT05868395 ↗ “Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone” NCT07608978 ↗ “Pola-R-CHP is a combination of rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin” NCT06743945 ↗ “Polatuzumab vedotin 30mg per vial 1.8 mg/kg, intravenous drip, Day 1 of each cycle” NCT07072208 ↗ “Rituximab, Gemcitabine, Oxaliplatin, Polatuzumab vedotin, Bendamustine, Rituximab” NCT04844866 ↗ “Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone” NCT07398638 ↗ “Polatuzumab vedotin: 1.8 mg/kg, intravenous drip, Day 1 of each cycle” NCT07499271 ↗ “Polatuzumab vedotin: 1.8 mg/kg, intravenous infusion, Day 1” NCT07680933 ↗ “Polatuzumab vedotin 1.8 mg/kg iv day 1 cycles 1-6” NCT04332822 ↗ “Polatuzumab vedotin: 1.8 mg/kg IV, Day 1” NCT07677813 ↗ “Polatuzumab Vedotin 1.8 mg/kg IV on D1” NCT05966233 ↗ |
| Known as | ACD-79B-VCMMAE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301582 ↗ |
| Known as | Anti-cd79b adc | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301582 ↗ |
| Known as | DCDS-4501A | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301582 ↗ |
| Known as | FCU-2711 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301582 ↗ |
| Known as | pola | “The POLARIX trial demonstrated the superiority of polatuzumab vedotin (Pola) over vincristine in the rituximab-cyclophosphamide-doxorubicin-vincristine-prednisone (R-CHOP)...” PMID 36521030 ↗ Jun 20232“The CD79b-targeted antibody-drug conjugate polatuzumab vedotin (pola), alone and with chemoimmunotherapy, has clinical efficacy and a tolerable safety profile in B-cell...” PMID 32770353 ↗ Aug 2020 “polatuzumab vedotin (Pola) added to rituximab” NCT04665765 ↗ |
| Known as | polatuzumab | “Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug, called monomethyl auristatin E.” NCT07638722 ↗ |
| Known as | Polatuzumab vedotin piiq | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301582 ↗ |
| Known as | Polatuzumab vedotina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301582 ↗ |
| Known as | Polatuzumab vedotine | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301582 ↗ |
| Known as | Polivy | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301582 ↗ |
| Known as | RG-7596 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301582 ↗ |
| Known as | RO-5541077-000 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301582 ↗ |
| Action | Deplete | “delivers vedotin to kill them” NCT04231877 ↗ |
| Modality | Other / unclassified | “The CD79b-targeted antibody-drug conjugate polatuzumab vedotin (pola), alone and with chemoimmunotherapy, has clinical efficacy and a tolerable safety profile in B-cell...” PMID 32770353 ↗ Aug 2020 |
| Route | Intravenous | “polatuzumab vedotin administered as a single agent by intravenous (IV) infusion” NCT01290549 ↗ |
| Target | CD79B | “Polatuzumab vedotin is an antibody-drug conjugate containing an anti-CD79B monoclonal antibody conjugated to the microtubule-disrupting agent monomethyl auristatin E.” PMID 25925619 ↗ Apr 2015 |