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 · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diffuse large B-cell lymphoma 2 milestones | |||||
| Filed | US (FDA) | Polivy | diffuse large B-cell lymphoma | 2022-08-15 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy®” gene.com ↗ |
| Filed | US (FDA) | — | diffuse large B-cell lymphoma | 2019-01-31 | “Files for regulatory review and approval of polatuzumab have been submitted to FDA.” roche.com ↗ |
| Filed large B-cell lymphoma 1 milestone | |||||
| Filed | US (FDA) | Polivy | large B-cell lymphoma | 2026-06-17 | “FDA has accepted the company’s supplemental Biologics License Application (sBLA) for Lunsumio VELO™ (mosunetuzumab-axgb), as a subcutaneous formulation, in combination with Polivy®” gene.com ↗ “FDA has accepted the company’s supplemental Biologics License Application (sBLA) for Lunsumio VELO™ (mosunetuzumab), as a subcutaneous formulation, in combination with Polivy®” roche.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Polivy | — | 2020-01-16 | europa.eu ↗ |
Trials 74 · started per year
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06015880 | May 2024 → Jun 2027 expected | high grade B-cell lymphoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT04970901 | Jun 2022 → Mar 2027 expected | B-cell non-Hodgkin lymphoma | ADC Therapeutics S.A. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04884035 | Sep 2021 → Dec 2028 expected | B-cell non-Hodgkin lymphoma | Celgene Corporation | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03467373 | Mar 2018 → Dec 2024 | B-cell neoplasm, non-Hodgkin lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01290549 | Mar 2011 → Jun 2012 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1/218 trials · 2 met primary · 2 missed | ||||||
| Phase 1/2 | NCT07415980 | Apr 2026 → Apr 2028 expected | diffuse large B-cell lymphoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07398638 | Feb 2026 → Feb 2029 expected | diffuse large B-cell lymphoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06040320 | Oct 2023 → May 2027 expected | post-transplant lymphoproliferative disease | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05455697 | Jan 2023 → Oct 2026 expected | high grade B-cell lymphoma | University of Washington | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04491370 | Aug 2021 → Aug 2026 overdue | Burkitt lymphoma, Hodgkins lymphoma, Richter transformation, diffuse large B-cell lymphoma +3 | New York Medical College | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04914741 | Jun 2021 → Dec 2023 overdue | high grade B-cell lymphoma | Peter MacCallum Cancer Centre, Australia | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04607772 | Nov 2020 → Dec 2025 | diffuse large B-cell lymphoma | Karyopharm Therapeutics Inc | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04231877 | Oct 2020 → Sep 2026 overdue | ALK-positive large B-cell lymphoma, T-cell/histiocyte rich large B cell lymphoma, high grade B-cell lymphoma, high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement +1 | University of Washington | Active not recruiting | Met primary |
| Phase 1/2 | NCT03677154 | May 2019 → Aug 2025 | diffuse large B-cell lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT03677141 | Mar 2019 → Oct 2023 | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 1/2 | NCT03671018 | Sep 2018 → Jan 2024 overdue | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 1/2 | NCT03533283 | May 2018 → Oct 2026 expected | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02729896 | Nov 2016 → Sep 2018 | lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT02600897 | Mar 2016 → Dec 2021 | diffuse large B-cell lymphoma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 1/2 | NCT02611323 | Mar 2016 → Aug 2022 | non-Hodgkin lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT02257567 | Oct 2014 → Oct 2021 | lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT01992653 | Nov 2013 → Dec 2018 | non-Hodgkin lymphoma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT01691898 | Sep 2012 → Mar 2017 | diffuse large B-cell lymphoma, follicular lymphoma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 243 trials | ||||||
| Phase 2 | NCT07502872 | Nov 2026 → Jan 2030 expected | high grade B-cell lymphoma | Brown University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07638722 | Oct 2026 → Apr 2034 expected | MALT lymphoma, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07702851 | Sep 2026 → Aug 2030 expected | diffuse large B-cell lymphoma | Yonsei University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07608978 | Jun 2026 → Dec 2028 expected | diffuse large B-cell lymphoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06594939 | Jun 2026 → Jun 2028 expected | diffuse large B-cell lymphoma | Medical College of Wisconsin | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07514169 | Mar 2026 → Dec 2028 expected | large B-cell lymphoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07397832 | Jan 2026 → Jul 2028 expected | diffuse large B-cell lymphoma | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07231250 | Jan → Sep 2026 overdue | diffuse large B-cell lymphoma | Li Zhiming | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07499271 | Jan 2026 → Dec 2027 expected | diffuse large B-cell lymphoma | The First Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| Phase 2 | NCT07184788 | Oct 2025 → Oct 2030 expected | aggressive B-cell non-Hodgkin lymphoma | Navy General Hospital, Beijing | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06665217 | Sep 2025 → Jan 2029 expected | diffuse large B-cell lymphoma | Navy General Hospital, Beijing | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07122609 | Aug 2025 → Aug 2026 overdue | relapsed/refractory diffuse large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07012980 | Jun 2025 → Jul 2026 overdue | diffuse large B-cell lymphoma | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07001540 | May 2025 → Nov 2027 expected | diffuse large B-cell lymphoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06743945 | Feb 2025 → Dec 2027 expected | diffuse large B-cell lymphoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06516978 | Oct 2024 → Oct 2028 expected | diffuse large B-cell lymphoma | The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06664411 | Sep 2024 → Dec 2029 expected | diffuse large B-cell lymphoma | Navy General Hospital, Beijing | Recruiting | No outcome recorded |
| Phase 2 | NCT06453044 | Sep 2024 → Mar 2028 expected | B-cell non-Hodgkin lymphoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06554600 | Aug 2024 → Aug 2026 overdue | diffuse large B-cell lymphoma | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT06071871 | Aug 2024 → Jul 2027 expected | large B-cell lymphoma | University College, London | Recruiting | No outcome recorded |
| Phase 2 | NCT06530511 | Aug 2024 → Feb 2026 overdue | diffuse large B-cell lymphoma | Affiliated Hospital of Nantong University | Recruiting | No outcome recorded |
| Phase 2 | NCT06043674 | Jan 2024 → Jan 2028 expected | B-cell chronic lymphocytic leukemia, Richter transformation | Christine Ryan | Recruiting | No outcome recorded |
| Phase 2 | NCT05868395 | Jan 2024 → May 2027 expected | mantle cell lymphoma | Medical University of Vienna | Recruiting | No outcome recorded |
| Phase 2 | NCT05966233 | Jan 2024 → Jan 2029 | diffuse large B-cell lymphoma | Fondazione Italiana Linfomi - ETS | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT06176729 | Oct 2023 → Oct 2025 overdue | diffuse large B-cell lymphoma | Yan Zhang, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05940051 | Jul 2023 → Jul 2025 | diffuse large B-cell lymphoma | Peng Liu | Unknown | No outcome recorded |
| Phase 2 | NCT05940064 | Jul 2023 → Jul 2025 | diffuse large B-cell lymphoma | Peng Liu | Unknown | No outcome recorded |
| Phase 2 | NCT06468943 | Jul 2023 → May 2026 overdue | chemotherapy-induced toxicity | The First Affiliated Hospital of Soochow University | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT05633615 | Jun 2023 → Jun 2030 expected | primary mediastinal large B-cell lymphoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 2 | NCT05615636 | Apr 2023 → Aug 2027 expected | B-cell non-Hodgkin lymphoma, Hodgkins lymphoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05798156 | Mar 2023 → Apr 2025 overdue | diffuse large B-cell lymphoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05498220 | Feb 2023 → Mar 2025 | diffuse large B-cell lymphoma | UNC Lineberger Comprehensive Cancer Center | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05410418 | Oct 2022 → Sep 2025 overdue | follicular lymphoma | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05283720 | Jun 2022 → Nov 2032 expected | non-Hodgkin lymphoma | Genmab | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05169658 | Mar 2022 → Apr 2025 | MALT lymphoma | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT05253495 | Feb 2022 → Dec 2027 expected | Hodgkins lymphoma, non-Hodgkin lymphoma | New York Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT04679012 | Sep 2021 → Jan 2027 expected | B-cell chronic lymphocytic leukemia, Richter transformation | Weill Medical College of Cornell University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04594798 | Sep 2021 → Jul 2027 expected | diffuse large B-cell lymphoma | University of Rochester | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04913103 | Sep 2021 → Aug 2026 overdue | mantle cell lymphoma | Czech Lymphoma Study Group | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04659044 | Apr 2021 → Mar 2024 | chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, marginal zone lymphoma | Academic and Community Cancer Research United | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04535102 | Jan 2021 → Mar 2022 | diffuse large B-cell lymphoma | University of Colorado, Denver | Withdrawn | No outcome recorded |
| Phase 2 | NCT04665765 | Jan 2021 → Jul 2022 overdue | B-cell lymphoma, unclassifiable, with features intermediate between diffuse large b-cell lymphoma and classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04479267 | Aug 2020 → Jun 2025 overdue | high grade B-cell lymphoma, high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement | Barbara Ann Karmanos Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 37 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT06522555 | Jul 2024 → Aug 2028 expected | diffuse large B-cell lymphoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05171647 | Apr 2022 → Feb 2025 overdue | non-Hodgkin lymphoma | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 3 | NCT04833114 | Apr 2021 → Dec 2025 | diffuse large B-cell lymphoma | GWT-TUD GmbH | Completed | No outcome recorded |
| Phase 3 | NCT04332822 | Aug 2020 → Dec 2025 overdue | diffuse large B-cell lymphoma | Nordic Lymphoma Group | Recruiting | No outcome recorded |
| Phase 3 | NCT04236141 | Jul 2020 → Jul 2021 | diffuse large B-cell lymphoma | Hoffmann-La Roche | Terminated | Missed primary |
| Phase 3 | NCT04182204 | Feb 2020 → Nov 2024 | diffuse large B-cell lymphoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT03274492 | Nov 2017 → Apr 2026 | diffuse large B-cell lymphoma | Hoffmann-La Roche | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT07072208 | Nov 2024 → May 2027 expected | diffuse large B-cell lymphoma | The First Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| Comparator or background therapy18 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 | NCT07308132 Background | Jan 2026 → Aug 2028 expected | non-Hodgkin lymphoma | Janssen Research & Development, LLC | 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 Stop: Business |
| 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 1/2 | 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 Stop: Business |
| 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 | NCT07812493 Background | Sep 2026 → Sep 2028 expected | diffuse large B-cell lymphoma | Pengpeng Xu | 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 3 | NCT06047080 Background | Sep 2023 → Oct 2027 expected | large B-cell lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 52
| Date | Issuer | Release |
|---|---|---|
| 2026-06-18 | Hoffmann-La Roche | Regulatory 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 ↗ |
| 2026-06-17 | Genentech, Inc. | Regulatory FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma gene.com ↗
FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma |
| 2026-03-23 | Chugai Pharmaceutical | Regulatory Chugai Obtains Regulatory Approval for Lunsumio and Polivy Combination Therapy for Additional Indication of Relapsed or Refractory Large B-cell Lymphoma chugai-pharm.co.jp ↗
This marks the first approval in the world for the combination therapy of Lunsumio and Polivy for this indication. |
| 2025-12-08 | Hoffmann-La Roche | Results Roche presents Lunsumio data showing potential across earlier treatment lines in indolent and aggressive lymphomas roche.com ↗
Lunsumio plus Polivy® (polatuzumab vedotin) data demonstrate meaningful improvements for people with R/R large B-cell lymphoma (LBCL)2,3 |
| 2025-12-08 | Genentech, Inc. | Results Genentech Presents Lunsumio Data Showing Potential Across Earlier Treatment Lines in Indolent and Aggressive Lymphomas gene.com ↗
Long term follow-up data from the Phase Ib/II GO40516 study demonstrated sustained improvements in patients treated with investigational SC Lunsumio in combination with Polivy compared to those treated with Rituxan® (rituximab) and Polivy in people with 2L+ LBCL. |
| 2025-11-03 | Hoffmann-La Roche | Results Roche to present new data from its broad and innovative haematology portfolio at ASH 2025 roche.com ↗
Long-term follow-up data from the phase Ib/II GO40516 study demonstrate sustained improvements in objective response rate (ORR) and progression-free survival with this combination in people with 2L+ large B-cell lymphoma (LBCL). |
| 2025-11-03 | Genentech, Inc. | Results Genentech to Present New Data From Its Broad and Innovative Hematology Portfolio at ASH 2025 gene.com ↗
Long-term follow-up data from the Phase Ib/II GO40516 study demonstrate sustained improvements in objective response rate (ORR) and progression-free survival with this combination in people with 2L+ large B-cell lymphoma (LBCL). |
| 2025-06-20 | Hoffmann-La Roche | Results Roche’s Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) presented today results from the phase III SUNMO [NCT05171647] study showing Lunsumio® (mosunetuzumab) administered subcutaneously in combination with Polivy® (polatuzumab vedotin) demonstrated a clinically meaningful and statistically significant improvement in its primary endpoints of progression-free survival (PFS) and objective response rate (ORR) compared to MabThera®/Rituxan® (rituximab), gemcitabine and oxaliplatin (R-GemOx), in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for transplant. |
| 2025-06-20 | Genentech, Inc. | Results Genentech’s Lunsumio and Polivy Combination Significantly Prolongs Remission for People With Relapsed or Refractory Large B-Cell Lymphoma gene.com ↗
Genentech’s Lunsumio and Polivy Combination Significantly Prolongs Remission for People With Relapsed or Refractory Large B-Cell Lymphoma |
| 2024-12-10 | Hoffmann-La Roche | Results New and updated data for Roche's fixed-duration Columvi and Lunsumio at ASH 2024 reinforce their potential to improve outcomes for people with lymphoma roche.com ↗
In the Lunsumio-Polivy arm, the ORR was 77.5% (95% CI: 61.6-89.2) versus 50.0% (95% CI: 33.8–66.2) for MabThera/Rituxan-Polivy, and the CR rate was 57.5% (95% CI: 40.9-73.0) versus 35.0% (95% CI: 20.6-51.7). |
| 2024-12-09 | Genentech, Inc. | Results New and Updated Data for Genentech’s Fixed-Duration Columvi and Lunsumio at ASH 2024 Reinforce Their Potential to Improve Outcomes for People With Lymphoma gene.com ↗ |
| 2024-12-08 | Hoffmann-La Roche | Results Five-year results confirm Roche’s Polivy combination therapy as new standard of care for previously untreated aggressive lymphoma roche.com ↗
Exploratory long-term follow-up analysis of the phase III POLARIX study indicated a positive trend in overall survival in favour of Polivy in combination with R-CHP for people with first-line diffuse large B-cell lymphoma (DLBCL)1 |
| 2024-12-08 | Genentech, Inc. | Results Five-Year Results Confirm Genentech’s Polivy Combination Therapy as New Standard of Care for Previously Untreated Aggressive Lymphoma gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today data from a five-year follow-up of the pivotal Phase III POLARIX study evaluating Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with untreated diffuse large B-cell lymphoma (DLBCL). |
| 2024-11-05 | Hoffmann-La Roche | Results Roche to present new and encouraging long-term follow-up data across broad haematology portfolio at ASH 2024 roche.com ↗
Five-year data from the phase III POLARIX study (abstract #469) reinforce the potential of Polivy in combination with MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to provide durable and lasting remissions and for the first time show a positive trend in overall survival (OS) for people with first-line diffuse large B-cell lymphoma (DLBCL), an area that previously had little advancement in nearly two decades.1 |
| 2024-11-05 | Genentech, Inc. | Results Genentech to Present New and Encouraging Long-term Follow-up Data Across Broad Hematology Portfolio at ASH 2024 gene.com ↗
Five-year data from the Phase III POLARIX study (abstract #469) reinforce the potential of Polivy in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to provide durable and lasting remissions |
| 2023-12-11 | Hoffmann-La Roche | Results New data for Roche’s Columvi and Lunsumio presented at ASH 2023 support continued benefit for people with lymphoma roche.com ↗
Results showed that at 24 months median follow-up, the median PFS was 11.4 months (95% CI: 6.2–18.7), and median OS was 23.3 months (95% CI: 14.8–NE), highlighting the combination’s potential in R/R LBCL. |
| 2023-12-10 | Genentech, Inc. | Results New Data for Genentech’s Columvi and Lunsumio Presented at ASH 2023 Support Continued Benefit for People With Lymphoma gene.com ↗
Results showed that at 24 months median follow-up, the median PFS was 11.4 months (95% CI: 6.2–18.7), and median OS was 23.3 months (95% CI: 14.8–NE), highlighting the combination’s potential in R/R LBCL. |
| 2023-04-19 | Hoffmann-La Roche | Regulatory [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 ↗ |
| 2023-04-19 | Genentech, Inc. | Regulatory FDA Approves Genentech's Polivy in Combination With R-CHP for People With Certain Types of Previously Untreated Diffuse Large B-Cell Lymphoma gene.com ↗
Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, an aggressive disease and the most common form of non-Hodgkin’s lymphoma in the U.S. |
| 2023-03-09 | Hoffmann-La Roche | Regulatory 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 ↗
U.S. FDA’s Oncologic Drugs Advisory Committee voted 11 to 2 in favour of the clinical benefit of the phase III POLARIX study of Polivy in combination with R-CHP for people with previously untreated diffuse large B-cell lymphoma (DLBCL) |
| 2023-03-09 | Genentech, Inc. | Regulatory FDA Advisory Committee Votes in Favor of the Clinical Benefit of Genentech's Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma gene.com ↗
U.S. FDA’s Oncologic Drugs Advisory Committee voted 11 to 2 in favor of the clinical benefit of the Phase III POLARIX study of Polivy in combination with R-CHP for people with previously untreated diffuse large B-cell lymphoma |
| 2022-12-12 | Hoffmann-La Roche | Results Roche presents new and updated data for Polivy in previously untreated diffuse large B-cell lymphoma at ASH 2022 roche.com ↗
Updated data from the phase III POLARIX study continue to demonstrate a statistically significant reduction in the risk of disease worsening or death for people with previously untreated diffuse large B-cell lymphoma (DLBCL)1 |
| 2022-12-12 | Genentech, Inc. | Results Genentech Presents New Data Demonstrating the Potential of Glofitamab and Mosunetuzumab as Fixed-Duration, Off-The-Shelf Treatment Options for Lymphoma gene.com ↗ |
| 2022-12-11 | Genentech, Inc. | Results Genentech Presents New and Updated Data for Polivy in Previously Untreated Diffuse Large B-Cell Lymphoma at ASH 2022 gene.com ↗
Updated data from the Phase III POLARIX study continue to demonstrate a statistically significant reduction in the risk of disease worsening or death for people with previously untreated diffuse large B-cell lymphoma (DLBCL) |
| 2022-11-03 | Hoffmann-La Roche | Results Roche to present data at ASH 2022 showcasing strength of haematology portfolio and expanding into new areas to address more patient needs roche.com ↗
New and updated data support use of Polivy in diffuse large B-cell lymphoma, including its potential as a treatment option for previously untreated patients2 |
| 2022-11-03 | Genentech, Inc. | Results Genentech to Present Data at ASH 2022 Showcasing Strength of Hematology Portfolio and Expanding Into New Areas to Address More Patient Needs gene.com ↗ |
| 2022-08-24 | Chugai Pharmaceutical | Regulatory Chugai Obtains Regulatory Approval for POLIVY for Additional Indication of Previously Untreated Diffuse Large B-cell Lymphoma chugai-pharm.co.jp ↗
Polivy plus R-CHP has been approved as a new treatment option, the first in 20 years, for untreated diffuse large B-cell lymphoma (DLBCL) following the approval for relapsed or refractory DLBCL last year |
| 2022-08-16 | Hoffmann-La Roche | Regulatory FDA accepts supplemental Biologics License Application for Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma roche.com ↗ |
| 2022-08-15 | Genentech, Inc. | Regulatory FDA Accepts Supplemental Biologics License Application for Genentech's Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). |
| 2022-05-25 | Hoffmann-La Roche | Regulatory Roche’s Polivy combination approved by European Commission for people with previously untreated diffuse large B-cell lymphoma roche.com ↗ |
| 2022-03-25 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma roche.com ↗ |
| 2021-12-14 | Hoffmann-La Roche | Results 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 ↗ |
| 2021-12-14 | Genentech, Inc. | Results Genentech’s Polivy Combination Reduced the Risk of Disease Worsening or Death by 27% in People With Previously Untreated Aggressive Form of Lymphoma gene.com ↗
Genentech’s Polivy Combination Reduced the Risk of Disease Worsening or Death by 27% in People With Previously Untreated Aggressive Form of Lymphoma |
| 2021-12-11 | Hoffmann-La Roche | Results Roche presents pivotal data at ASH 2021 for novel cancer immunotherapy mosunetuzumab roche.com ↗
Data from the phase Ib/II GO40516 study evaluating mosunetuzumab in combination with Polivy® (polatuzumab vedotin) showed promising efficacy and favourable safety in heavily pretreated patients with aggressive R/R NHL with an objective response rate (ORR) of 65.0% and a CR rate of 48.3%. |
| 2021-12-11 | Genentech, Inc. | Results Genentech Presents Pivotal Data at ASH 2021 for Novel Cancer Immunotherapy Mosunetuzumab gene.com ↗
CRS occurred in 18% of patients, and all events occurred in Cycle 1 and were Grade 1-2. |
| 2021-12-10 | Chugai Pharmaceutical | Regulatory Chugai Files for Additional Indication of Polivy for Previously Untreated Diffuse Large B-cell Lymphoma chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it filed a regulatory application with the Ministry of Health, Labour and Welfare for approval of an additional indication |
| 2021-11-23 | Hoffmann-La Roche | Results Roche to present new pivotal data at ASH 2021 from broad and comprehensive portfolio, challenging treatment standards for people with blood disorders roche.com ↗
Phase III POLARIX trial showed Polivy plus R-CHP was the first treatment in two decades to significantly improve outcomes in newly diagnosed diffuse large B-cell lymphoma (DLBCL) versus the standard of care1 |
| 2021-11-23 | Genentech, Inc. | Results Genentech to Present New Pivotal Data at ASH 2021 From Broad and Comprehensive Portfolio, Challenging Treatment Standards for People With Blood Disorders gene.com ↗
Phase III POLARIX trial showed Polivy plus R-CHP was the first treatment in two decades to significantly improve outcomes in newly diagnosed diffuse large B-cell lymphoma versus the standard of care |
| 2021-08-09 | Hoffmann-La Roche | Results [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 ↗
Pivotal phase III POLARIX trial comparing Polivy in combination with chemotherapy regimen R-CHP versus the standard of care R-CHOP in treatment of first-line diffuse large B-cell lymphoma (DLBCL) met its primary endpoint of investigator-assessed progression-free survival |
| 2021-08-08 | Genentech, Inc. | Results Phase III Study Shows Genentech'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 gene.com ↗
Phase III Study Shows Genentech'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 |
| 2021-06-04 | Hoffmann-La Roche | Results Roche presents latest advances with immunotherapies in non-Hodgkin lymphoma roche.com ↗
Data for investigational CD20xCD3 bispecific antibodies and new combination regimens with Polivy showed enhanced clinical benefits for people with non-Hodgkin lymphoma in early studies |
| 2021-06-04 | Genentech, Inc. | Results Genentech Presents Latest Advances With Immunotherapies in Non-Hodgkin’s Lymphoma gene.com ↗
Data for investigational CD20xCD3 bispecific antibodies and new combination regimens with Polivy showed enhanced clinical benefits for people with non-Hodgkin’s lymphoma in early studies |
| 2020-12-07 | Hoffmann-La Roche | Results 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 ↗
Furthermore, new data from an extension cohort showed a CR rate of 38.7% (n=41/106) with Polivy plus BR. |
| 2020-01-21 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s Polivy for people with previously treated aggressive lymphoma roche.com ↗ |
| 2019-11-15 | Hoffmann-La Roche | Regulatory CHMP recommends conditional EU approval of Roche’s Polivy for people with previously treated aggressive lymphoma roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Polivy® (polatuzumab vedotin) in combination with bendamustine plus MabThera® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not candidates for a haematopoietic stem cell transplant. |
| 2019-06-11 | Hoffmann-La Roche | Regulatory FDA grants Roche’s Polivy accelerated approval for people with previously treated aggressive lymphoma roche.com ↗
Accelerated approval was granted for this indication based on complete response rates observed in a randomised, controlled clinical trial. |
| 2019-06-10 | Genentech, Inc. | Regulatory FDA Grants Genentech’s Polivy Accelerated Approval for People With Previously Treated Aggressive Lymphoma gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies. |
| 2019-02-19 | Hoffmann-La Roche | Regulatory FDA grants Priority Review to Roche's polatuzumab vedotin in previously treated aggressive lymphoma roche.com ↗ |
| 2019-02-18 | Genentech, Inc. | Regulatory FDA Grants Priority Review to Genentech’s Polatuzumab Vedotin in Previously Treated Aggressive Lymphoma gene.com ↗
FDA Grants Priority Review to Genentech’s Polatuzumab Vedotin in Previously Treated Aggressive Lymphoma |
| 2018-12-03 | Hoffmann-La Roche | Results Longer-term follow-up data demonstrate sustained benefit of polatuzumab vedotin-based treatment in relapsed or refractory diffuse large B-cell lymphoma roche.com ↗
Polatuzumab vedotin in combination with MabThera/Rituxan (rituximab) plus bendamustine more than doubled overall survival, compared to MabThera/Rituxan plus bendamustine alone in the phase Ib/II GO29365 study |
| 2017-12-10 | Hoffmann-La Roche | Results Phase II data showed Roche’s investigational polatuzumab vedotin plus bendamustine and MabThera/Rituxan (BR) increased complete response rates compared to BR alone in previously treated aggressive lymphoma roche.com ↗ |
| 2017-12-10 | Genentech, Inc. | Results Phase II Data Showed Genentech’s Investigational Polatuzumab Vedotin Plus Bendamustine and Rituxan (BR) Increased Complete Response Rates Compared to BR Alone in Previously Treated Aggressive Lymphoma gene.com ↗
Phase II Data Showed Genentech’s Investigational Polatuzumab Vedotin Plus Bendamustine and Rituxan (BR) Increased Complete Response Rates Compared to BR Alone in Previously Treated Aggressive Lymphoma |
All press releases naming this drug 55 releases
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 96 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 ↗91“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 ↗ |
| 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 |