Drugs / Obinutuzumab
Obinutuzumab
also known as
GA101 · GAZYVA · Gazyvaro · RO5072759 · AFUTUZUMAB · GA101 : Obinutuzumab · HUMAB CD20 · OBI · +5 more
Monoclonal antibody targets MS4A1
Regulatory milestones approvals, filings & regulatory actions · 17 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed B-cell chronic lymphocytic leukemia 2 milestones | |||||
| Filed | Japan (PMDA) | Gazyva | B-cell chronic lymphocytic leukemia | 2022-03-07 | “Chugai filed a regulatory application with the Ministry of Health, Labour and Welfare (MHLW), for approval of an anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva ®” chugai-pharm.co.jp ↗ |
| Filed | EU (EMA) | IMBRUVICA | B-cell chronic lymphocytic leukemia | 2019-01-22 | “submitted to EMA for the expanded use of IMBRUVICA (ibrutinib) in combination with obinutuzumab in previously untreated adults with chronic lymphocytic leukemia” jnj.com ↗ |
| Filed chronic lymphocytic leukemia/small lymphocytic lymphoma 1 milestone | |||||
| Filed | US (FDA) | Gazyva | chronic lymphocytic leukemia/small lymphocytic lymphoma | 2018-10-16 | “today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Priority Review for IMBRUVICA ® (ibrutinib) in...” abbvie.com ↗ |
| Filed follicular lymphoma, susceptibility to 3 milestones | |||||
| Filed | US (FDA) | Gazyva | follicular lymphoma, susceptibility to | 2017-08-27 | “FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva® (obinutuzumab)” gene.com ↗ |
| Filed | US (FDA) | Gazyva | follicular lymphoma, susceptibility to | 2015-11-05 | “the FDA has accepted for priority review the company's supplemental Biologics License Application (sBLA) for Gazyva in the treatment of patients with follicular lymphoma (FL)” gene.com ↗ |
| Filed | EU (EMA) | Gazyva | follicular lymphoma, susceptibility to | — | “Marketing applications for Gazyva based on the GADOLIN study results have also been submitted to other regulatory authorities, including the European Medicines Agency (EMA),...” gene.com ↗ “Marketing applications for Gazyva have also been submitted to other health authorities, including the European Medicines Agency” gene.com ↗ |
| Filed lupus nephritis 1 milestone | |||||
| Filed | US (FDA) | Gazyva | lupus nephritis | 2025-03-04 | “the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of...” roche.com ↗ “data from the phase III REGENCY study were used to file a supplemental Biologics License Application with the US Food and Drug Administration (FDA).” roche.com ↗ “FDA has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva® (obinutuzumab) for the treatment of lupus nephritis.” gene.com ↗ |
| Filed systemic lupus erythematosus 2 milestones | |||||
| Filed | US (FDA) | Gazyva | systemic lupus erythematosus | 2026-04-20 | “the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of...” roche.com ↗ “FDA has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva® (obinutuzumab) for the treatment of systemic lupus erythematosus (SLE).” gene.com ↗ |
| Filed | US (FDA) | Gazyva | systemic lupus erythematosus | 2026-03-02 | “FDA accepts application for Gazyva/Gazyvaro for the treatment of the most common form of lupus” roche.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | GAZYVA | — | 2014-12-24 – 2025-10-17 | fda.gov ↗ |
| Approved | EU (EMA) | Gazyvaro | — | 2014-07-22 | europa.eu ↗ |
| Approved | US (FDA) | GAZYVA | — | 2013-11-01 | fda.gov ↗ |
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EU approved 2014
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 137 trials | ||||||
| Phase 1 | NCT07548255 | Apr 2026 → Mar 2029 expected | mantle cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06824701 | Sep 2025 → Jan 2032 expected | B-cell non-Hodgkin lymphoma | University of Utah | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06351527 | Apr 2024 → Jun 2027 expected | neoplasm of mature B-cells | InnoCare Pharma Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06265220 | Apr 2024 → Aug 2027 expected | lupus nephritis, systemic lupus erythematosus | Artiva Biotherapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06547944 | Jan 2024 → Dec 2025 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | Institute of Hematology & Blood Diseases Hospital, China | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05943496 | Oct 2023 → Jan 2027 expected | B-cell chronic lymphocytic leukemia | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT05653271 | Jan 2023 → Mar 2026 | Burkitt lymphoma, follicular lymphoma, high grade B-cell lymphoma, marginal zone lymphoma +1 | Acepodia Biotech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05211336 | Apr 2022 → Jun 2024 overdue | diffuse large B-cell lymphoma of the central nervous system | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04599634 | Dec 2021 → Mar 2024 | chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT04464798 | Nov 2020 → Jan 2023 | lymphoma | Celgene Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04073147 | May 2020 → Nov 2021 | primary central nervous system lymphoma | Klinikum Stuttgart | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04277637 | Mar 2020 → May 2027 expected | neoplasm of mature B-cells | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04245722 | Mar 2020 → Sep 2023 | B-cell chronic lymphocytic leukemia | Fate Therapeutics | Terminated | No outcome recorded |
| Phase 1 | NCT04023071 | Oct 2019 → Oct 2023 | B-cell neoplasm, acute myeloid leukemia | Fate Therapeutics | Terminated | No outcome recorded |
| Phase 1 | NCT03432741 | Mar 2018 → Aug 2022 | Hodgkins lymphoma, breast adenocarcinoma, mycosis fungoides, nodal marginal zone B-cell lymphoma | Mayo Clinic | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03467373 | Mar 2018 → Dec 2024 | B-cell neoplasm, non-Hodgkin lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03113695 | Dec 2017 → May 2022 | Richter transformation, chronic lymphocytic leukemia/small lymphocytic lymphoma | University of California, San Diego | Completed | No outcome recorded |
| Phase 1 | NCT03198650 | Jun 2017 → Oct 2022 | B-cell chronic lymphocytic leukemia | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02992522 | Feb 2017 → Apr 2020 overdue | Burkitt lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma | Beth Christian | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02877550 | Feb 2017 → Apr 2020 | follicular lymphoma | Swiss Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02611908 | Jun 2016 → Nov 2019 | B-cell chronic lymphocytic leukemia | Michael Choi | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02569476 | Jan 2016 → Sep 2020 | B-cell neoplasm | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT02537613 | Dec 2015 → Mar 2020 overdue | B-cell chronic lymphocytic leukemia | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02586051 | Nov 2015 → Nov 2018 | end stage renal failure | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02453087 | Aug 2015 → Jul 2019 | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02457598 | Jun 2015 → Sep 2024 | B-cell neoplasm | Gilead Sciences | Terminated | No outcome recorded |
| Phase 1 | NCT02417285 | May 2015 → May 2019 | diffuse large B-cell lymphoma | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02292225 | Feb 2015 → Nov 2016 | chronic lymphocytic leukemia/small lymphocytic lymphoma | SecuraBio | Terminated | No outcome recorded |
| Phase 1 | NCT02324257 | Dec 2014 → Sep 2019 | cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02296918 | Dec 2014 → Aug 2021 | chronic lymphocytic leukemia/small lymphocytic lymphoma, prolymphocytic leukemia | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT02220842 | Dec 2014 → Jan 2020 | lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02174172 | Aug 2014 → Nov 2019 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01685892 | Nov 2012 → May 2018 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01644253 | Sep 2012 → Feb 2020 | B-cell chronic lymphocytic leukemia, peripheral T-cell lymphoma, not otherwise specified | Aptevo Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT01680991 | Sep 2012 → Dec 2014 | B-cell neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01300247 | May 2011 → Jan 2013 | B-cell chronic lymphocytic leukemia | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00825149 | Feb 2009 → Nov 2015 | non-Hodgkin lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/231 trials · 2 met primary · 1 missed | ||||||
| Phase 1/2 | NCT07847957 | Jan → Apr 2027 expected | B-cell chronic lymphocytic leukemia | Dana-Farber Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07520006 | May 2026 → May 2033 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Nurix Therapeutics, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07441954 | Mar 2026 → Dec 2027 expected | indolent B-cell non-Hodgkin lymphoma | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06357676 | May 2025 → Nov 2027 expected | mantle cell lymphoma | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06592170 | Aug 2024 → Aug 2025 overdue | lymphoma | The First Hospital of Jilin University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06090539 | Dec 2023 → Oct 2027 expected | non-Hodgkin lymphoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05861050 | Aug 2023 → Feb 2027 | mantle cell lymphoma | City of Hope Medical Center | Suspended | No outcome recorded |
| Phase 1/2 | NCT04722601 | Sep 2021 → Mar 2023 | follicular lymphoma | University of Chicago | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04855695 | Jul 2021 → Jun 2027 expected | mantle cell lymphoma | Austin I Kim | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03930953 | May 2019 → Apr 2027 expected | non-Hodgkin lymphoma | Celgene Corporation | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03492125 | May 2018 → Nov 2023 | chronic lymphocytic leukemia/small lymphocytic lymphoma | MingSight Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 1/2 | NCT03135262 | Jun 2017 → Apr 2020 | diffuse large B-cell lymphoma, follicular lymphoma | Hoffmann-La Roche | Terminated | 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 | NCT02631577 | Dec 2015 → Oct 2018 | follicular lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT02624986 | Dec 2015 → May 2019 | non-Hodgkin lymphoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1/2 | NCT02596971 | Dec 2015 → Apr 2018 | diffuse large B-cell lymphoma, follicular lymphoma, susceptibility to | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT02558816 | Oct 2015 → Apr 2019 | mantle cell lymphoma | Nantes University Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT02315768 | Aug 2015 → Apr 2022 | B-cell chronic lymphocytic leukemia | University of California, San Diego | Completed | No outcome recorded |
| Phase 1/2 | NCT02427451 | Aug 2015 → Dec 2021 overdue | B-cell chronic lymphocytic leukemia | Kerry Rogers | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02406742 | Jul 2015 → Jul 2020 | B-cell chronic lymphocytic leukemia | Celgene Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT02391545 | Dec 2014 → Jan 2017 | follicular lymphoma | SecuraBio | Terminated | No outcome recorded |
| Phase 1/2 | NCT02257567 | Oct 2014 → Oct 2021 | lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT02229422 | Sep 2014 → Oct 2025 | chronic lymphocytic leukemia/small lymphocytic lymphoma | University of California, San Diego | Unknown | No outcome recorded |
| Phase 1/2 | NCT01995669 | May 2014 → Jan 2023 | chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, marginal zone lymphoma | M.D. Anderson Cancer Center | Completed | Met primary |
| Phase 1/2 | NCT01992653 | Nov 2013 → Dec 2018 | non-Hodgkin lymphoma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02055820 | Nov 2013 → Jun 2017 | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT01582776 | Oct 2012 → Jul 2018 | follicular lymphoma | The Lymphoma Academic Research Organisation | Completed | Met primary |
| Phase 1/2 | NCT01691898 | Sep 2012 → Mar 2017 | diffuse large B-cell lymphoma, follicular lymphoma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00517530 | Sep 2007 → Nov 2013 | lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2136 trials · 6 met primary · 4 missed | ||||||
| Phase 2 | NCT07674810 | Dec 2026 → Apr 2027 expected | B-cell chronic lymphocytic leukemia | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07842523 | Nov 2026 → Dec 2029 expected | systemic sclerosis | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07690891 | Oct 2026 → Dec 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Medical College of Wisconsin | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07624799 | Sep 2026 → Sep 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | French Innovative Leukemia Organisation | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07799220 | Sep 2026 → Sep 2028 expected | mantle cell lymphoma | Memorial Sloan Kettering Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07710157 | Jul 2026 → Jun 2028 expected | minimal change disease | Medical University Innsbruck | Recruiting | No outcome recorded |
| Phase 2 | NCT07003295 | Jul 2026 → Aug 2027 expected | mantle cell lymphoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07514169 | Mar 2026 → Dec 2028 expected | large B-cell lymphoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07233330 | Feb 2026 → Mar 2029 expected | idiopathic nephrotic syndrome | Mario Negri Institute for Pharmacological Research | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07268521 | Jan 2026 → May 2028 expected | Cryoglobulinemic vasculitis | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Show all 136 trials opens the full record — a long page | ||||||
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07163611 | Oct 2025 → Apr 2028 expected | membranous glomerulonephritis | Radboud University Medical Center | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05786768 | Oct 2023 → Oct 2027 expected | idiopathic steroid-sensitive nephrotic syndrome | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 332 trials · 13 met primary · 2 missed | ||||||
| Phase 3 | NCT06120673 | Oct 2025 → Jan 2028 | idiopathic membranous glomerulonephritis | The University of Queensland | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT06943872 | Jun 2025 → Sep 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 3 | NCT06781944 | Oct 2024 → May 2028 expected | idiopathic membranous glomerulonephritis | Huashan Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT06428019 | Aug 2024 → Mar 2028 expected | B-cell chronic lymphocytic leukemia | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT06191744 | Feb 2024 → Nov 2037 expected | follicular lymphoma | Genmab | Recruiting | No outcome recorded |
| Phase 3 | NCT05627557 | Mar 2023 → Sep 2025 overdue | idiopathic nephrotic syndrome | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05057494 | Sep 2022 → Jul 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05045664 | Jul 2022 → Sep 2027 expected | B-cell non-Hodgkin lymphoma | Heidelberg University | Recruiting | No outcome recorded |
| Phase 3 | NCT05197192 | Apr 2022 → May 2028 expected | B-cell chronic lymphocytic leukemia | German CLL Study Group | Recruiting | No outcome recorded |
| Phase 3 | NCT05100862 | Mar 2022 → Jul 2028 expected | marginal zone lymphoma | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04702256 | Dec 2021 → Dec 2031 expected | lupus nephritis, systemic lupus erythematosus | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT05058404 | Dec 2021 → Jul 2028 expected | follicular lymphoma | Fondazione Italiana Linfomi - ETS | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04963296 | Oct 2021 → Sep 2025 overdue | systemic lupus erythematosus | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 3 | NCT04629248 | Jun 2021 → Dec 2025 overdue | idiopathic membranous glomerulonephritis | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 3 | NCT04269902 | Mar 2021 → Oct 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 3 | NCT04608318 | Mar 2021 → Sep 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | German CLL Study Group | Active not recruiting | Met primary |
| Phase 3 | NCT04221477 | Aug 2020 → Aug 2024 overdue | lupus nephritis | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 3 | NCT04285567 | May 2020 → Mar 2024 | B-cell chronic lymphocytic leukemia | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT03701282 | Feb 2019 → May 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03406156 | Aug 2018 → Oct 2021 | chronic lymphocytic leukemia/small lymphocytic lymphoma | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02950051 | Dec 2016 → Feb 2024 | B-cell chronic lymphocytic leukemia | German CLL Study Group | Completed | Met primary |
| Phase 3 | NCT02475681 | Jun 2015 → Feb 2019 overdue | B-cell chronic lymphocytic leukemia | Acerta Pharma BV | Active not recruiting | Met primary |
| Phase 3 | NCT01980875 | Apr 2015 → May 2016 | B-cell chronic lymphocytic leukemia | Gilead Sciences | Terminated | No outcome recorded |
| Phase 3 | NCT02264574 | Oct 2014 → Mar 2018 | B-cell chronic lymphocytic leukemia | Pharmacyclics LLC. | Completed | Met primary |
| Phase 3 | NCT01905943 | Nov 2013 → Dec 2016 | B-cell chronic lymphocytic leukemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01659099 | Sep 2012 → Aug 2016 | diffuse large B-cell lymphoma | The Lymphoma Academic Research Organisation | Terminated | Missed primary |
| Phase 3 | NCT01287741 | Jul 2011 → Apr 2016 | diffuse large B-cell lymphoma | Hoffmann-La Roche | Terminated | Missed primary |
| Phase 3 | NCT01332968 | Jul 2011 → Feb 2016 | non-Hodgkin lymphoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT01059630 | Apr 2010 → Sep 2014 | non-Hodgkin lymphoma | Genentech, Inc. | Completed | Met primary |
| Phase 3 | NCT02053610 | Dec 2009 → Aug 2013 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT01998880 | Dec 2009 → Aug 2012 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT01010061 | Dec 2009 → Jul 2012 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT07611214 | Apr 2026 → Mar 2029 expected | lupus nephritis | Aurinia Pharmaceuticals Inc. | Recruiting | No outcome recorded |
| Phase 4 | NCT07355699 | Nov 2025 → Sep 2027 expected | marginal zone lymphoma | Beijing Tongren Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT03817853 | Feb 2019 → Aug 2020 | follicular lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07126678 | Jul 2025 → Jul 2028 expected | follicular lymphoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| — | NCT05950997 | Apr 2024 → May 2026 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| — | NCT05797948 | Jul 2022 → Jun 2024 | B-cell non-Hodgkin lymphoma | The First Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| Comparator or background therapy79 trials | ||||||
| Phase 1 | NCT07107490 Background | Oct 2025 → Sep 2028 expected | small cell lung carcinoma | Chugai Pharmaceutical | Recruiting | No outcome recorded |
| Phase 1 | NCT06922604 Background | Jul 2025 → Jan 2029 | central nervous system non-hodgkin lymphoma | City of Hope Medical Center | Suspended | No outcome recorded |
| Phase 1 | NCT06916767 Background | Jul 2025 → Dec 2027 expected | B-cell chronic lymphocytic leukemia | Paolo Caimi, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT06624085 Background | Apr 2025 → Mar 2027 expected | lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06291220 Background | Jan 2025 → Jul 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | AbbVie | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06192888 Background | Jan 2024 → Jan 2028 expected | mantle cell lymphoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05894447 Background | Nov 2023 → Dec 2025 | urothelial carcinoma | Weill Medical College of Cornell University | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT05673057 Background | Dec 2022 → May 2026 | leukemia, myeloid neoplasm | Molecular Partners AG | Completed | No outcome recorded |
| Phase 1 | NCT05364424 Background | Nov 2022 → Oct 2025 | diffuse large B-cell lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT05169515 Background | Oct 2022 → Sep 2029 expected | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1 | NCT04970901 Background | Jun 2022 → Mar 2027 expected | B-cell non-Hodgkin lymphoma | ADC Therapeutics S.A. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05219513 Background | Feb 2022 → Jul 2024 | non-Hodgkin lymphoma | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04826003 Background | Jul 2021 → Nov 2024 | colorectal cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT04739813 Background | Jul 2021 → May 2026 overdue | Burkitt lymphoma, diffuse large B-cell lymphoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04843904 Background | Apr 2021 → Jun 2025 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04657302 Background | Jan 2021 → Oct 2022 | lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT04434196 Background | Dec 2020 → May 2024 | non-Hodgkin lymphoma | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04551352 Background | Oct 2020 → Jul 2022 | cutaneous melanoma, mucosal melanoma, uveal melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT04578600 Background | Oct 2020 → Dec 2023 | MALT lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, hairy cell leukemia +2 | Joseph Tuscano | Completed | No outcome recorded |
| Phase 1 | NCT04313608 Background | Jun 2020 → Oct 2021 | B-cell neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03983954 Background | Oct 2019 → Mar 2027 expected | cervical squamous cell carcinoma, colorectal cancer, endometrial cancer, esophageal cancer +14 | NeoTX Therapeutics Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03759184 Background | Jul → Dec 2019 | B-cell neoplasm, lymphoid leukemia | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT03866239 Background | May 2019 → Mar 2024 | colorectal cancer | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1 | NCT03539484 Background | Jul 2018 → Jul 2019 | cancer | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1 | NCT03369964 Comparator | Mar → Dec 2018 | non-Hodgkin lymphoma | Hoffmann-La Roche | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT03039114 Background | Feb 2017 → Mar 2021 | lymphoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02336048 Background | Jun 2015 → Sep 2018 | B-cell chronic lymphocytic leukemia | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1 | NCT02100852 Background | Mar 2014 → Nov 2017 | chronic lymphocytic leukemia/small lymphocytic lymphoma | TG Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01671904 Background | Jan 2014 → Aug 2018 | B-cell chronic lymphocytic leukemia | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT06634589 Background | Nov 2024 → Dec 2028 expected | B-cell non-Hodgkin lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06464185 Background | Apr 2024 → Mar 2026 overdue | B-cell non-Hodgkin lymphoma | Institute of Hematology & Blood Diseases Hospital, China | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05896163 Background | Aug 2023 → Apr 2026 | diffuse large B-cell lymphoma | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT05533775 Background | Nov 2022 → Nov 2029 expected | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05159388 Background | Sep 2021 → Apr 2025 | cancer | Servier Bio-Innovation LLC | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04787042 Background | Aug 2021 → Jun 2025 overdue | head and neck squamous cell carcinoma, melanoma, non-small cell lung carcinoma, renal cell carcinoma +1 | Simcha IL-18, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03980171 Background | Aug 2019 → Nov 2026 expected | follicular lymphoma | Peter MacCallum Cancer Centre, Australia | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04077723 Background | Aug 2019 → Mar 2027 expected | non-Hodgkin lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03533283 Background | May 2018 → Oct 2026 expected | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03223610 Background | Feb 2018 → Dec 2026 expected | Burkitt lymphoma, diffuse large B-cell lymphoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03010358 Background | Jul 2017 → Apr 2021 | B-cell prolymphocytic leukemia, Richter transformation, anemia, chronic lymphocytic leukemia/small lymphocytic lymphoma +4 | Alexey Danilov, MD | Completed | No outcome recorded |
| Phase 1/2 | NCT03075696 Background | Feb 2017 → Mar 2029 expected | non-Hodgkin lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02529852 Background | Nov 2015 → Oct 2022 | lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT07634289 Background | Dec 2026 → Dec 2031 expected | diffuse large B-cell lymphoma | Olivia Newton-John Cancer Research Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07502872 Background | Nov 2026 → Jan 2030 expected | high grade B-cell lymphoma | Brown University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07711483 Background | Oct 2026 → Oct 2028 expected | B-cell non-Hodgkin lymphoma, large B-cell lymphoma | Massachusetts General Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07702851 Background | Sep 2026 → Aug 2030 expected | diffuse large B-cell lymphoma | Yonsei University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07599423 Background | Jul 2026 → Jul 2030 expected | diffuse large B-cell lymphoma | The First Affiliated Hospital of Soochow University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07613788 Background | May 2026 → Nov 2028 expected | large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07326371 Background | Mar 2026 → Jul 2027 expected | diffuse large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07231250 Background | Jan → Sep 2026 overdue | diffuse large B-cell lymphoma | Li Zhiming | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07480850 Background | Jan 2026 → Jan 2028 expected | diffuse large B-cell lymphoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07240194 Background | Sep 2025 → Dec 2028 expected | large B-cell lymphoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT07012980 Background | Jun 2025 → Jul 2026 overdue | diffuse large B-cell lymphoma | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06918015 Background | May 2025 → May 2028 expected | follicular lymphoma | Zhejiang Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06961500 Background | May 2025 → Nov 2030 expected | B-cell non-Hodgkin lymphoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06867536 Background | Apr 2025 → Aug 2028 expected | relapsed/refractory diffuse large B-cell lymphoma | Liling Zhang | Recruiting | No outcome recorded |
| Phase 2 | NCT06806033 Background | Mar 2025 → Jan 2027 expected | aggressive B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 2 | NCT06567366 Background | Sep 2024 → Sep 2027 expected | large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06474481 Background | Jul 2024 → Dec 2027 expected | — | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06043674 Background | Jan 2024 → Jan 2028 expected | B-cell chronic lymphocytic leukemia, Richter transformation | Christine Ryan | Recruiting | No outcome recorded |
| Phase 2 | NCT05833763 Background | Oct 2023 → Apr 2032 expected | mantle cell lymphoma | Australasian Leukaemia and Lymphoma Group | Recruiting | No outcome recorded |
| Phase 2 | NCT05848765 Comparator | Sep 2023 → May 2029 expected | follicular lymphoma | University of Birmingham | Recruiting | No outcome recorded |
| Phase 2 | NCT05478512 Background | Jul 2023 → May 2026 overdue | B-cell chronic lymphocytic leukemia | GIMEMA Foundation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04880863 Background | Oct 2021 → Jan 2024 | non-small cell lung carcinoma | NeoTX Therapeutics Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04703686 Background | Mar 2021 → Jan 2023 | indolent B-cell non-Hodgkin lymphoma, mantle cell lymphoma, primary mediastinal large B-cell lymphoma | The Lymphoma Academic Research Organisation | Completed | No outcome recorded |
| Phase 2 | NCT04189588 Comparator | Mar → Nov 2020 | — | TerSera Therapeutics LLC | Completed | No outcome recorded |
| Phase 2 | NCT04934930 Background | Jan 2020 → Aug 2025 | follicular lymphoma | Meir Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT03492775 Comparator | Dec 2017 → Nov 2021 | indolent B-cell non-Hodgkin lymphoma | Prof. Dr. Wolfgang Hiddemann | Completed | No outcome recorded |
| Phase 2 | NCT02867384 Comparator | Nov 2016 → Nov 2023 | chronic graft versus host disease | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 3 | NCT06284122 Comparator | Jun 2024 → Nov 2028 expected | follicular lymphoma | The Lymphoma Academic Research Organisation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06073821 Comparator | Nov 2023 → Feb 2032 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06084936 Background | Oct 2023 → Aug 2027 expected | lymphoma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT04796922 Background | Dec 2022 → Dec 2028 | follicular lymphoma, marginal zone lymphoma | Incyte Corporation | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT04408638 Background | Feb 2021 → Mar 2028 expected | diffuse large B-cell lymphoma | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 3 | NCT03836261 Comparator | Feb 2019 → Apr 2027 expected | B-cell chronic lymphocytic leukemia | Acerta Pharma BV | Active not recruiting | Met primary |
| Phase 3 | NCT03737981 Background | Jan 2019 → Jan 2025 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | National Cancer Institute (NCI) | Active not recruiting | Missed primary |
| Phase 3 | NCT03462719 Comparator | Apr 2018 → Feb 2021 overdue | B-cell chronic lymphocytic leukemia | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT02612311 Comparator | Nov 2015 → Feb 2023 | B-cell chronic lymphocytic leukemia | TG Therapeutics, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02242942 Background | Dec 2014 → Aug 2018 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Hoffmann-La Roche | Completed | Met primary |
News releases announcing trial results or a regulatory action · 147
| Date | Issuer | Release |
|---|---|---|
| 2026-07-15 | Hoffmann-La Roche | Regulatory FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy roche.com ↗
Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has granted Priority Review to the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of primary membranous nephropathy (pMN). |
| 2026-07-14 | Genentech, Inc. | Regulatory FDA Grants Priority Review to Genentech’s Gazyva for Adults With Primary Membranous Nephropathy gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s supplemental Biologics License Application (sBLA) for Gazyva® (obinutuzumab) for the treatment of primary membranous nephropathy (pMN). |
| 2026-06-12 | AbbVie | Results AbbVie Presents New Data at EHA 2026 Congress for VENCLEXTA®/VENCLYXTO® (venetoclax) in First-Line Chronic Lymphocytic Leukemia Highlighting Long-Term Treatment Outcomes for Patients: Nine-Year Results abbvie.com ↗
Venetoclax in combination with obinutuzumab has shown positive responses across several key measures compared to obinutuzumab plus chlorambucil, including an extended increase in progression-free survival in previously untreated patients with chronic lymphocytic leukemia, |
| 2026-05-14 | Nippon Shinyaku Co., Ltd. | Regulatory ヒト化抗CD20モノクローナル抗体「ガザイバ」 特発性ネフローゼ症候群に対して適応拡大申請 nippon-shinyaku.co.jp ↗
抗悪性腫瘍剤／ヒト化抗CD20モノクローナル抗体「ガザイバ®点滴静注1000mg」［一般名：オビヌツズマブ（遺伝子組換え）］について、特発性ネフローゼ症候群に対する適応拡大の申請を、本日、中外製薬が厚生労働省に行いましたのでお知らせいたします。 |
| 2026-05-14 | Chugai Pharmaceutical | Regulatory Filing of Humanized Anti-CD20 Monoclonal Antibody Gazyva for Additional Indication of Idiopathic Nephrotic Syndrome chugai-pharm.co.jp ↗
Chugai filed a regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for the anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva ® for Intravenous Infusion 1000 mg [generic name: obinutuzumab (genetical recombination)] for an additional indication of idiopathic nephrotic syndrome (INS). |
| 2026-04-21 | Hoffmann-La Roche | Regulatory FDA accepts application for Roche’s Gazyva/Gazyvaro for the treatment of the most common form of lupus roche.com ↗
Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of systemic lupus erythematosus (SLE). |
| 2026-04-20 | Genentech, Inc. | Regulatory FDA Accepts Application for Genentech’s Gazyva for the Treatment of the Most Common Form of Lupus gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva® (obinutuzumab) for the treatment of systemic lupus erythematosus (SLE). |
| 2026-03-06 | Hoffmann-La Roche | Results New England Journal of Medicine publishes phase III ALLEGORY data showing Roche’s Gazyva/Gazyvaro significantly reduces disease activity in the most common form of lupus roche.com ↗
The study demonstrated a statistically significant and clinically meaningful benefit in the primary endpoint. |
| 2026-03-06 | Genentech, Inc. | Results New England Journal of Medicine Publishes Phase III ALLEGORY Data Showing Genentech’s Gazyva Significantly Reduces Disease Activity in the Most Common Form of Lupus gene.com ↗
The study demonstrated a statistically significant and clinically meaningful benefit in the primary endpoint. |
| 2026-02-16 | Hoffmann-La Roche | Results Roche announces positive phase III results for Gazyva/Gazyvaro in primary membranous nephropathy, marking a significant milestone in this autoimmune disease roche.com ↗
Results show that significantly more people achieved complete remission at two years (104 weeks) with Gazyva/Gazyvaro versus tacrolimus. |
| 2026-02-15 | Genentech, Inc. | Results Genentech Announces Positive Phase III Results for Gazyva in Primary Membranous Nephropathy, Marking a Significant Milestone in This Autoimmune Disease gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III MAJESTY study in adults with primary membranous nephropathy met its primary endpoint, showing statistically significant and clinically meaningful results with Gazyva® (obinutuzumab). |
| 2025-12-09 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s Gazyva/Gazyvaro for adults with active lupus nephritis roche.com ↗ |
| 2025-12-07 | BeOne Medicines | Results Sonrotoclax Data at ASH 2025 Confirm Foundational Potential Across B-cell Malignancies beonemedicines.com ↗
In the 320 mg efficacy-evaluable cohort (n=30), the ORR was 93%, with CR/CRi in 43% of patients. |
| 2025-12-06 | Adaptive Biotechnologies | Results Adaptive Biotechnologies Showcases Leadership in Hematology-Oncology MRD with New clonoSEQ® Data Driving Treatment Interventions at 2025 ASH Annual Meeting adaptivebiotech.com ↗ |
| 2025-12-02 | AbbVie | Results AbbVie to Feature New Data at ASH 2025 Showcasing Continued Advances Across Novel Treatment Modalities in Multiple Blood Cancers abbvie.com ↗ |
| 2025-11-20 | Nippon Shinyaku Co., Ltd. | Regulatory 抗悪性腫瘍剤／ヒト化抗CD20モノクローナル抗体「ガザイバ」未治療の慢性リンパ性白血病に対してベネトクラクスとの併用可能に nippon-shinyaku.co.jp ↗
本日、抗悪性腫瘍剤／ヒト化抗CD20モノクローナル抗体「ガザイバ®点滴静注1000 mg」［一般名：オビヌツズマブ（遺伝子組換え）］において、電子添文改訂により未治療の「CD20陽性の慢性リンパ性白血病（小リンパ球性リンパ腫を含む）」に対する抗悪性腫瘍剤／BCL-2阻害剤「ベネクレクスタ®錠10mg・50mg・100mg」［一般名：ベネトクラクス］との併用療法が可能になりましたので、お知らせいたします。 |
| 2025-11-20 | Chugai Pharmaceutical | Regulatory Anti-Cancer Agent/Humanized Anti-CD20 Monoclonal Antibody Gazyva, Now Available for Use in Combination with Venetoclax for Previously Untreated Chronic Lymphocytic Leukemia chugai-pharm.co.jp ↗
This revision of the electronic package insert is based on the results of clinical studies evaluating the efficacy and safety of combination therapy with venetoclax and obinutuzumab for previously untreated chronic lymphocytic leukemia (including small lymphocytic lymphoma). |
| 2025-11-12 | Artiva Biotherapeutics, Inc. | Results Artiva Biotherapeutics Announces Positive Initial Safety and Translational Data Supporting Deep B-Cell Depletion with AlloNK® in Autoimmune Disease artivabio.com ↗ |
| 2025-11-03 | Hoffmann-La Roche | Results Positive phase III data for Roche’s Gazyva/Gazyvaro show significant reduction in disease activity for systemic lupus erythematosus roche.com ↗
The study met its primary endpoint showing a higher percentage of people achieved a minimum four-point improvement in SLE Responder Index 4 (SRI-4) at one year (52 weeks) with Gazyva/Gazyvaro versus standard therapy. |
| 2025-11-02 | Genentech, Inc. | Results Positive Phase III Data for Genentech’s Gazyva Show Significant Reduction in Disease Activity for Systemic Lupus Erythematosus gene.com ↗
The study met its primary endpoint showing a higher percentage of people achieved a minimum four-point improvement in SLE Responder Index 4 (SRI-4) at one year (52 weeks) with Gazyva versus standard therapy. |
| 2025-10-30 | Chugai Pharmaceutical | Results Roche Announces Global Phase III INShore Study Topline Results on Gazyva for Idiopathic Nephrotic Syndrome in Children and Young Adults chugai-pharm.co.jp ↗
The primary endpoint of sustained complete remission (SCR) at one year (week 52) after treatment initiation showed statistically significant and clinically meaningful improvement in the Gazyva treatment group compared to the mycophenolate mofetil (MMF) group. |
| 2025-10-28 | Hoffmann-La Roche | Results Positive phase III results for Roche’s Gazyva/Gazyvaro in children and young adults with idiopathic nephrotic syndrome roche.com ↗
The study met its primary endpoint, with more people achieving sustained complete remission at one year (week 52) with Gazyva/Gazyvaro compared with mycophenolate mofetil (MMF). |
| 2025-10-27 | Genentech, Inc. | Results Positive Phase III Results for Genentech’s Gazyva in Children and Young Adults With Idiopathic Nephrotic Syndrome gene.com ↗
The study met its primary endpoint, with more people achieving sustained complete remission at one year (week 52) with Gazyva compared with mycophenolate mofetil (MMF). |
| 2025-10-20 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Gazyva®/Gazyvaro®(obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients. |
| 2025-10-19 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Gazyva for the Treatment of Lupus Nephritis gene.com ↗
FDA Approves Genentech’s Gazyva for the Treatment of Lupus Nephritis |
| 2025-10-17 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Gazyva/Gazyvaro for lupus nephritis roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gazyva®/Gazyvaro® (obinutuzumab) in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis. |
| 2025-06-06 | AstraZeneca | Regulatory Fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia in the 1st-line setting astrazeneca.com ↗
A fixed-duration regimen of AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, has been approved in the European Union (EU) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). |
| 2025-04-29 | AstraZeneca | Regulatory Fixed-duration Calquence-based regimens recommended for approval in the EU by CHMP for 1st-line chronic lymphocytic leukaemia astrazeneca.com ↗
A fixed-duration regimen of AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, has been recommended for approval in the European Union (EU) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). |
| 2025-03-05 | Hoffmann-La Roche | Regulatory FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of lupus nephritis. |
| 2025-03-04 | Genentech, Inc. | Regulatory FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva® (obinutuzumab) for the treatment of lupus nephritis. |
| 2025-02-07 | Hoffmann-La Roche | Results New England Journal of Medicine publishes new data for Roche’s Gazyva/Gazyvaro which shows superiority over standard therapy in people with active lupus nephritis roche.com ↗
Nearly half of patients on Gazyva/Gazyvaro plus standard therapy achieved a complete renal response (CRR), with a statistically significant and clinically meaningful improvement, compared to standard treatment alone1 |
| 2025-02-07 | Genentech, Inc. | Results New England Journal of Medicine Publishes New Data for Genentech’s Gazyva Which Shows Superiority Over Standard Therapy in People With Active Lupus Nephritis gene.com ↗
Nearly half of patients on Gazyva plus standard therapy achieved a complete renal response (CRR), with a statistically significant and clinically meaningful improvement, compared to standard treatment alone |
| 2024-12-08 | AstraZeneca | Results Fixed-duration Calquence plus venetoclax demonstrated superior progression-free survival vs. standard of care in previously untreated chronic lymphocytic leukaemia, with 77% of patients progression free at three years in AMPLIFY Phase III trial astrazeneca.com ↗
Calquence plus venetoclax with obinutuzumab demonstrated a 58% reduction in the risk of disease progression or death compared to standard-of-care chemoimmunotherapy (HR 0.42; 95% CI 0.30-0.59; p<0.0001). |
| 2024-12-07 | Adaptive Biotechnologies | Results Adaptive Biotechnologies Announces New Data at the 66th ASH Annual Meeting Highlighting Advances in MRD Testing with clonoSEQ® and Its Impact on Blood Cancer Treatment Decisions adaptivebiotech.com ↗
This Phase 2 study evaluating the use of venetoclax and obinutuzumab in treatment-naïve CLL patients found that those achieving undetectable MRD (<10⁻⁶) after nine cycles could discontinue therapy early. |
| 2024-11-05 | BeOne Medicines | Results BeiGene Highlights Innovative Hematology Portfolio Across B-cell Malignancies at ASH 2024 beonemedicines.com ↗
Results from the LTE (long-term extension rollover) study of patients with treatment-naïve and R/R CLL also showed that treatment with BRUKINSA as a single agent or as an investigational treatment in combination with obinutuzumab achieved high overall and complete response rates. |
| 2024-09-26 | Hoffmann-La Roche | Results Positive phase III results for Roche’s Gazyva/Gazyvaro show superiority to standard therapy alone in people with lupus nephritis roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline results from the phase III REGENCY study of Gazyva®/Gazyvaro® (obinutuzumab) in people with active lupus nephritis. |
| 2024-09-25 | Genentech, Inc. | Results Positive Phase III Results for Genentech’s Gazyva Show Superiority to Standard Therapy Alone in People With Lupus Nephritis gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive topline results from the Phase III REGENCY study of Gazyva® (obinutuzumab) in people with active lupus nephritis. |
| 2024-07-29 | AstraZeneca | Results Fixed-duration Calquence plus venetoclax, with or without obinutuzumab, significantly improved progression-free survival in 1st-line chronic lymphocytic leukaemia in AMPLIFY Phase III trial astrazeneca.com ↗
a fixed duration of AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) |
| 2024-05-14 | BeOne Medicines | Results BeiGene Highlights New Hematology Portfolio and Pipeline Data at EHA2024 beonemedicines.com ↗
Results of an intra-patient comparative analysis from ROSEWOOD study of BRUKINSA plus obinutuzumab in patients with R/R follicular lymphoma (FL), supporting the efficacy benefit of the combination in this patient population (Abstract P1143) |
| 2024-03-07 | BeOne Medicines | Regulatory BeiGene Announces FDA Accelerated Approval of BRUKINSA for the Treatment of Relapsed or Refractory Follicular Lymphoma beonemedicines.com ↗
The indication is approved under accelerated approval based on response rate and durability of response, marking BRUKINSA’s fifth indication in B-cell malignancies in the U.S. |
| 2023-12-09 | Adaptive Biotechnologies | Results Adaptive Biotechnologies Announces New Data Highlighting the Clinical Relevance of MRD Testing with clonoSEQ® in Patients with Blood Cancers at the 65th ASH Annual Meeting adaptivebiotech.com ↗
In patients achieving MRD negative status after induction and consolidation, omission of obinutuzumab maintenance did not result in worsening PFS compared to those that did receive maintenance. |
| 2023-11-29 | Janssen Research & Development, LLC | Results Johnson & Johnson highlights its preeminent leadership in hematology through differentiated blood cancer portfolio and pipeline with new clinical and real-world data at ASH jnj.com ↗
A nearly five-year follow-up study from GLOW in older patients with comorbidities will include an analysis of I+V treatment in comparison to chlorambucil plus obinutuzumab (Clb+O) demonstrating sustained overall survival (OS) and progression-free survival (PFS). |
| 2023-11-17 | BeOne Medicines | Regulatory BeiGene Receives European Commission Approval for BRUKINSA® (zanubrutinib) for the Treatment of Relapsed or Refractory Follicular Lymphoma beonemedicines.com ↗ |
| 2023-10-13 | BeOne Medicines | Regulatory BeiGene Receives Positive CHMP Opinion for BRUKINSA® (zanubrutinib) in Relapsed or Refractory Follicular Lymphoma beonemedicines.com ↗
CHMP recommends approval for BRUKINSA plus obinutuzumab as a treatment for adult patients who have received at least two prior lines of therapy |
| 2023-07-12 | BeOne Medicines | Regulatory BeiGene Announces FDA Acceptance of sNDA for Fifth BRUKINSA® Indication beonemedicines.com ↗ |
| 2023-06-15 | BeOne Medicines | Results BeiGene Highlights Significant BRUKINSA® (zanubrutinib) Data at the 17th International Conference on Malignant Lymphoma beonemedicines.com ↗
Notably, an updated analysis with a median follow-up of 20.2 months, reinforced previous results from the Phase 2 ROSEWOOD trial of BRUKINSA in combination with obinutuzumab, |
| 2023-06-09 | AbbVie | Results AbbVie's VENCLYXTO®/VENCLEXTA® (venetoclax) Continues to Show Sustained Progression-Free Survival (PFS) in Chronic Lymphocytic Leukemia (CLL) Patients abbvie.com ↗
Six-year median follow-up from the Phase 3 CLL14 study shows continued PFS after treatment with venetoclax plus obinutuzumab compared to treatment with chlorambucil plus obinutuzumab in previously untreated patients with CLL and co-existing conditions |
| 2023-06-09 | BeOne Medicines | Results BeiGene Highlights Promising Data from Blood Cancer Portfolio and Pipeline at the European Hematology Association Hybrid Congress beonemedicines.com ↗
Additionally, in an updated analysis of the Phase 2 ROSEWOOD study, BRUKINSA plus obinutuzumab, a humanized type II anti-CD20 monoclonal antibody, demonstrated clinically meaningful activity and manageable safety profile in patients with heavily pretreated relapsed/refractory (R/R) follicular lymphoma (FL). |
| 2023-05-25 | BeOne Medicines | Results BeiGene Presentations at the 2023 ASCO Annual Meeting Reinforce Promise Across Oncology Portfolio beonemedicines.com ↗
In an updated analysis of the ROSEWOOD study, BRUKINSA in combination with obinutuzumab demonstrated clinically meaningful activity and manageable safety profile in patients with heavily pretreated relapsed/refractory (R/R) follicular lymphoma (FL). |
| 2022-12-23 | Chugai Pharmaceutical | Regulatory Humanized Anti-CD20 Monoclonal Antibody Gazyva Approved for Additional Indication of Chronic Lymphocytic Leukemia chugai-pharm.co.jp ↗ |
| 2022-12-10 | Adaptive Biotechnologies | Results Adaptive Biotechnologies Highlights New Data Showcasing the Clinical Utility of clonoSEQ® MRD Testing in Patients with Blood Cancers at the 64th ASH Annual Meeting adaptivebiotech.com ↗
The results showed 88% of patients in complete remission were MRD-negative at the end of their treatment, and their MRD status was predictive of progression-free survival. |
| 2022-11-30 | AstraZeneca | Results AstraZeneca showcases strength of haematology portfolio and pipeline across multiple hard-to-treat conditions at ASH 2022 astrazeneca.com ↗
A retrospective pooled analysis will show the benefit of adding obinutuzumab to Calquence in the front-line CLL setting in patients with select genomic characteristics. |
| 2022-11-10 | Artiva Biotherapeutics, Inc. | Results Artiva Biotherapeutics Presents Preclinical Data for AB-101, an Optimized Allogeneic NK Cell Therapy Candidate, at SITC 2022 Annual Meeting artivabio.com ↗
Data highlights the optimized cell prole of AB-101 and combination data with monoclonal antibodies rituximab, obinutuzumab, cetuximab, and trastuzumab |
| 2022-06-10 | Hoffmann-La Roche | Results Roche announces positive data from broad blood cancer portfolio at European Hematology Association Annual Meeting roche.com ↗
Updated data from phase III CLL14 study of Venclexta®/Venclyxto® (venetoclax) plus Gazyva®/Gazyvaro® (obinutuzumab) showed more than 60% of previously untreated people with chronic lymphocytic leukaemia remained in remission five years after starting treatment[1] |
| 2022-06-10 | AbbVie | Results New Data Demonstrates AbbVie's VENCLYXTO®/VENCLEXTA® Combination Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients After Four Years Off Treatment abbvie.com ↗
PFS was significantly superior for venetoclax plus obinutuzumab compared to chlorambucil plus obinutuzumab (median not reached [NR] vs. 36.4 months, p<0.0001) |
| 2022-06-10 | BeOne Medicines | Results BeiGene Highlights Growing Portfolio and Pipeline Targeting Hematologic Malignancies at European Hematology Association 2022 Congress beonemedicines.com ↗
The ROSEWOOD trial met its primary endpoint, with a 68.3% ORR in the zanubrutinib plus obinutuzumab arm versus 45.8% in the obinutuzumab arm (p = 0.0017) and median follow-up of 12.5 months. |
| 2022-06-09 | Genentech, Inc. | Results Genentech Announces Positive Data From Broad Blood Cancer Portfolio at European Hematology Association Annual Meeting gene.com ↗ |
| 2022-06-09 | AstraZeneca | Results AstraZeneca demonstrates pipeline and portfolio strength across malignant and rare haematological diseases at EHA 2022 astrazeneca.com ↗
Calquence in combination with obinutuzumab shows longer-term overall survival at five years in 1st-line chronic lymphocytic leukaemia |
| 2022-06-04 | AstraZeneca | Results Calquence plus obinutuzumab demonstrated sustained survival benefit in 1st-line chronic lymphocytic leukaemia with 90% of patients surviving five years in ELEVATE-TN trial astrazeneca.com ↗
An estimated 90% of patients treated with the Calquence combination were alive at five years versus 84% for Calquence alone and 82% for chlorambucil plus obinutuzumab. |
| 2022-04-19 | Acepodia Biotech, Inc. | Results Acepodia Presents Preclinical Data on its gamma delta T cell Therapy Candidate ACE1831 at 2022 AACR Meeting acepodia.com ↗
ACE 1831 and Obinutuzumab combination provides additional potency against CD20-expressing cancer cells. |
| 2022-03-07 | Chugai Pharmaceutical | Regulatory Filing of Humanized Anti-CD20 Monoclonal Antibody Gazyva for Additional Indication of Chronic Lymphocytic Leukemia chugai-pharm.co.jp ↗
Chugai files for regulatory approval following the results from the Phase III ELEVATE-TN study evaluating Gazyva and acalabrutinib in patients with untreated CLL |
| 2021-12-13 | Adaptive Biotechnologies | Results Adaptive Biotechnologies Announces New Data Demonstrating the Benefit of Serial MRD Testing with the clonoSEQ® Assay in Patients with Blood Cancers at the 63rd ASH Annual Meeting adaptivebiotech.com ↗
33 patients stopped therapy based on predefined uMRD criteria. |
| 2021-12-11 | Hoffmann-La Roche | Results Roche presents pivotal data at ASH 2021 for novel cancer immunotherapy mosunetuzumab roche.com ↗
A phase I/Ib NP30179 dose-escalation study evaluating glofitamab as a monotherapy and in combination with Gazyva®/Gazyvaro® (obinutuzumab) following pretreatment with Gazyva/Gazyvaro in patients with R/R B-cell NHL showed promising activity in both R/R FL and R/R mantle cell lymphoma (MCL), an uncommon but aggressive form of lymphoma with poor prognosis for those who progress. |
| 2021-12-11 | Janssen Research & Development, LLC | Results New Data from Phase 3 GLOW Study Show Fixed-Duration Treatment with IMBRUVICA® (ibrutinib) Plus Venetoclax Demonstrated Deeper and Sustained Undetectable Minimal Residual Disease Outcomes in First-Line Chronic Lymphocytic Leukemia jnj.com ↗
New secondary endpoint data from the Phase 3 GLOW study (NCT03462719) showed that fixed-duration treatment with I+V resulted in undetectable minimal residual disease (uMRD) responses that were deeper compared to patients treated with chlorambucil plus obinutuzumab |
| 2021-12-11 | Genentech, Inc. | Results Genentech Presents Pivotal Data at ASH 2021 for Novel Cancer Immunotherapy Mosunetuzumab gene.com ↗
Preliminary results in heavily pretreated patients with R/R FL showed high response rates across all treatment groups, including high-risk subgroups, with an ORR of 81.0% for the glofitamab monotherapy group and an ORR of 100% for the glofitamab plus Gazyva |
| 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 ↗
Glofitamab As Monotherapy and in Combination with Obinutuzumab Induces High Complete Response Rates in Patients (pts) with Multiple Relapsed or Refractory (R/R) Follicular Lymphoma (FL)#128 oral presentation |
| 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 ↗
Glofitamab As Monotherapy and in Combination with Obinutuzumab Induces High Complete Response Rates in Patients (pts) with Multiple Relapsed or Refractory (R/R) Follicular Lymphoma (FL) |
| 2021-10-14 | Hoffmann-La Roche | Regulatory Roche’s Gazyvaro shorter 90-minute infusion time approved in Europe for people with previously treated or untreated follicular lymphoma roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced European Medicines Agency (EMA) approval of a new, shorter 90-minute Gazyvaro® (obinutuzumab) infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma (FL). |
| 2021-06-12 | Janssen Research & Development, LLC | Results New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia jnj.com ↗
The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus Clb+O as first-line treatment of CLL; the study also showed improved duration of remission and significantly improved depth of remission. |
| 2021-06-12 | Janssen Research & Development, LLC | Results New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia jnj.com ↗ |
| 2021-06-12 | AbbVie | Results IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study abbvie.com ↗
The PFS benefit with I+V was consistent across pre-specified subgroups, including patients 65 years and older and those with comorbidities (CIRS >6). |
| 2021-06-11 | Hoffmann-La Roche | Results Roche announces data at EHA2021 reinforcing efficacy of Venclexta/Venclyxto combinations in chronic lymphocytic leukaemia and acute myeloid leukaemia roche.com ↗
The fixed treatment duration (12 months) study indicated that the chemotherapy-free Venclexta/Venclyxto plus Gazyva/Gazyvaro (obinutuzumab) regimen had an estimated PFS rate of 74.0% vs 35.4% for Gazyva/Gazyvaro plus chlorambucil. |
| 2021-06-11 | AbbVie | Results New Data Shows AbbVie's VENCLYXTO®/VENCLEXTA® Fixed Duration Combination Demonstrates Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients after Three Years off Treatment abbvie.com ↗
At four years after randomization, the PFS rate for patients treated with the VENCLYXTO/VENCLEXTA-based combination was 74 percent compared to 35.4 percent for patients treated with obinutuzumab and chlorambucil. |
| 2021-06-10 | Genentech, Inc. | Results Genentech Announces Data at EHA2021 Reinforcing Efficacy of Venclexta Combinations in Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia gene.com ↗
The fixed treatment duration (12 months) study indicated that the chemotherapy-free Venclexta plus Gazyva® (obinutuzumab) regimen had an estimated PFS rate of 74.0% vs 35.4% for Gazyva plus chlorambucil. |
| 2021-06-07 | AstraZeneca | Results Calquence demonstrated fewer incidences of atrial fibrillation versus ibrutinib in previously treated patients with chronic lymphocytic leukaemia and sustained patient benefit at four years in the front-line setting astrazeneca.com ↗
Separately, updated results at four years of follow up from the ELEVATE-TN Phase III trial continued to show a strong PFS benefit for Calquence as combination therapy or as monotherapy in previously untreated patients with CLL. |
| 2021-05-19 | AstraZeneca | Results AstraZeneca ASCO 2021 data support ambition to revolutionise cancer outcomes by treating earlier and transforming the patient experience astrazeneca.com ↗
Four-year follow-up data from the ELEVATE-TN trial will confirm the sustained clinical benefit of either Calquence monotherapy or Calquence in combination with obinutuzumab, providing flexibility to tailor treatment for adults with treatment-naïve chronic lymphocytic leukaemia (CLL). |
| 2020-12-06 | AbbVie | Results Combined Data from Multiple Phase 3 Studies of IMBRUVICA® (ibrutinib) Show Efficacy and Safety in High-Risk, Previously Untreated Chronic Lymphocytic Leukemia (CLL) and Real-World Data Indicating Low Biomarker Testing Rates for These Patients abbvie.com ↗
At 42 months, PFS rates were higher across high-risk genomic subgroups in patients treated with IMBRUVICA (63 to 82 percent) compared to those receiving chlorambucil with or without obinutuzumab (6 to 34 percent) |
| 2020-12-06 | Adaptive Biotechnologies | Results Adaptive Biotechnologies Announces New Clinical Data Demonstrating Impact of clonoSEQ® Assay on Patients with Blood Cancers at the 62nd ASH Annual Meeting adaptivebiotech.com ↗
The subset of data presented at ASH analyzes MRD and clonal growth patterns in both cohorts of patients to better understand disease dynamics during and after treatment. |
| 2020-12-05 | Hoffmann-La Roche | Results Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for people with relapsed or refractory chronic lymphocytic leukaemia roche.com ↗
In this analysis, after treatment with fixed-duration Venclexta/Venclyxto plus Gazyva/Gazyvaro, the estimated clonal growth rate was slower and lower, suggesting more effective MRD eradication in these patients compared to those treated with Gazyva/Gazyvaro plus chlorambucil. |
| 2020-12-05 | Genentech, Inc. | Results Genentech Announces New Data Reinforcing the Long-Term Benefit of Venclexta-Based Combination for People With Relapsed or Refractory Chronic Lymphocytic Leukemia gene.com ↗
In this analysis, after treatment with fixed-duration Venclexta plus Gazyva, the estimated clonal growth rate was slower and lower, suggesting more effective MRD eradication in these patients compared to those treated with Gazyva plus chlorambucil. |
| 2020-12-05 | AbbVie | Results AbbVie Presents Extended Follow-Up Data for Fixed Duration Treatment VENCLEXTA®/VENCLYXTO® (venetoclax) in Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗
The four-year, follow-up analysis showed an OS rate of 85.3% with Ven-Obi versus 83.1% with chlorambucil in combination with obinutuzumab (Obi-Clb; HR 0.85, 95% CI [0.54-1.35]; P=0.4929). |
| 2020-11-19 | AstraZeneca | Results AstraZeneca demonstrates strengths in haematology with robust data at ASH 2020 astrazeneca.com ↗
Data on Calquence in combination with venetoclax and either obinutuzumab or rituximab in patients with CLL, showing a safety profile consistent with previous trials with high complete responses and undetectable minimal residual disease rates after a median follow-up of 26.9 months, with minimal to no drug-drug interactions in the Phase Ib ACE-CL-003 trial |
| 2020-03-12 | Hoffmann-La Roche | Regulatory European Commission approves Venclyxto plus Gazyvaro for adults with previously untreated chronic lymphocytic leukaemia roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto® (venetoclax) in combination with Gazyvaro® (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). |
| 2020-03-12 | AbbVie | Regulatory AbbVie Receives European Commission Approval of VENCLYXTO® Combination Regimen for Patients with Previously-Untreated Chronic Lymphocytic Leukemia abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that the European Commission (EC) has approved VENCLYXTO ® (venetoclax) in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who were previously untreated. |
| 2020-01-31 | AbbVie | Regulatory AbbVie Receives Positive CHMP Opinion for VENCLYXTO® as a Chemotherapy-Free Combination Regimen for Patients with Previously Untreated Chronic Lymphocytic Leukemia abbvie.com ↗
The positive CHMP opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which is expected to deliver its final decision in the first half of 2020. |
| 2019-12-08 | Hoffmann-La Roche | Results New data demonstrate the continued clinical benefit of fixed-duration, chemotherapy-free Venclexta/Venclyxto-based treatments in chronic lymphocytic leukaemia roche.com ↗
Higher rates of MRD-negativity in peripheral blood (76% vs. 35%; p<0.001) and bone marrow (57% vs. 17; p<0.001%) were observed at the end of treatment in people treated with Venclexta/Venclyxto plus Gazyva/Gazyvaro versus Gazyva/Gazyvaro plus chlorambucil, respectively. |
| 2019-12-08 | Genentech, Inc. | Results New Data Demonstrate the Continued Clinical Benefit of Fixed-duration, Chemotherapy-free Venclexta-based Treatments in Chronic Lymphocytic Leukemia gene.com ↗
At a median follow-up of more than three years (39.6 months), when all patients had been off therapy for a minimum of two years, Venclexta plus Gazyva showed high response rates, including MRD-negativity. |
| 2019-12-07 | Genentech, Inc. | Results Genentech Announces New Data on Novel CD20-CD3 Bispecific Cancer Immunotherapies in People With Difficult-to-Treat Lymphomas gene.com ↗ |
| 2019-12-07 | AstraZeneca | Results Calquence significantly prolonged the time patients lived without disease progression or death in previously untreated chronic lymphocytic leukaemia astrazeneca.com ↗
Full results from the Phase III ELEVATE TN trial showed 93% of patients on Calquence combined with obinutuzumab vs. 47% of patients on chlorambucil plus obinutuzumab remained free of disease progression or death at 24 months |
| 2019-11-11 | Hoffmann-La Roche | Results Roche’s Gazyva (obinutuzumab), in combination with standard of care, more than doubles the percentage of lupus nephritis patients achieving complete renal response, compared to standard of care alone roche.com ↗
The study met the primary endpoint with Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrating superiority compared to placebo plus standard of care. |
| 2019-11-09 | Genentech, Inc. | Results Genentech’s Gazyva (obinutuzumab), in Combination With Standard of Care, More Than Doubles the Percentage of Lupus Nephritis Patients Achieving Complete Renal Response, Compared To Standard of Care Alone gene.com ↗
The study met the primary endpoint with Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrating superiority compared to placebo plus standard of care. |
| 2019-11-06 | Hoffmann-La Roche | Results Roche to present new data highlighting breadth of haematology portfolio and pipeline at the American Society of Hematology 2019 Annual Meeting roche.com ↗
Dual CD20-Targeted Therapy With Concurrent CD20-TCB and Obinutuzumab Shows Highly Promising Clinical Activity and Manageable Safety in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma: Preliminary Results From a Phase Ib Trial |
| 2019-11-06 | Genentech, Inc. | Results Genentech to Present New Data Highlighting Breadth of Hematology Portfolio and Pipeline at the American Society of Hematology 2019 Annual Meeting gene.com ↗
Dual CD20-Targeted Therapy With Concurrent CD20-TCB and Obinutuzumab Shows Highly Promising Clinical Activity and Manageable Safety in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma: Preliminary Results From a Phase Ib Trial |
| 2019-09-18 | Hoffmann-La Roche | Regulatory FDA grants Breakthrough Therapy Designation for Roche’s Gazyva (obinutuzumab) in Lupus Nephritis roche.com ↗ |
| 2019-09-17 | Genentech, Inc. | Regulatory FDA Grants Breakthrough Therapy Designation for Genentech’s Gazyva (Obinutuzumab) in Lupus Nephritis 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 Breakthrough Therapy Designation (BTD) to Gazyva® (obinutuzumab) for adults with lupus nephritis. |
| 2019-06-20 | BeOne Medicines | Results BeiGene Announces Phase 1b Clinical Results of Zanubrutinib in Combination with GAZYVA® (Obinutuzumab) in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Follicular Lymphoma at the 15th International Conference on Malignant Lympho beonemedicines.com ↗
These data demonstrated that zanubrutinib, in combination with the anti-CD20 monoclonal antibody obinutuzumab was generally well-tolerated, with the majority of adverse events being grade 1 or 2. |
| 2019-06-10 | Genentech, Inc. | Results Genentech’s Gazyva (Obinutuzumab) Delivers Positive Topline Results for Phase II Lupus Nephritis Study gene.com ↗
The study met its primary endpoint, showing Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrated enhanced efficacy compared to placebo plus standard of care alone in achieving complete renal response at one year. |
| 2019-06-06 | AstraZeneca | Results Calquence Phase III ELEVATE-TN trial met primary endpoint at interim analysis in previously-untreated chronic lymphocytic leukaemia astrazeneca.com ↗
The trial met its primary endpoint; Calquence in combination with obinutuzumab demonstrated a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab. |
| 2019-06-04 | Hoffmann-La Roche | Results Pivotal phase III CLL14 results for Venclexta/Venclyxto in combination with Gazyva/Gazyvaro for chronic lymphocytic leukaemia presented at ASCO 2019 and published in the New England Journal of Medicine roche.com ↗
Venclexta/Venclyxto plus Gazyva/Gazyvaro showed improvements across multiple efficacy measures compared to Gazyva/Gazyvaro plus chlorambucil, including progression-free survival and deep remissions as determined by minimal residual disease measurement |
| 2019-06-04 | Genentech, Inc. | Results Pivotal Phase III CLL14 Results for Venclexta in Combination With Gazyva for Chronic Lymphocytic Leukemia Presented at ASCO 2019 and Published in the New England Journal of Medicine gene.com ↗
At two years, one year after stopping treatment, nearly nine out of ten patients (88.2 percent) in the Venclexta plus Gazyva arm remained progression-free, compared to 64.1 percent in the Gazyva plus chlorambucil arm. |
| 2019-06-04 | AbbVie | Results AbbVie Presents Data from Venetoclax Chemotherapy-Free Combination Regimen for Patients with Previously Untreated Chronic Lymphocytic Leukemia abbvie.com ↗
The results demonstrate that venetoclax plus obinutuzumab prolonged progression-free survival (PFS) and achieved higher rates of complete response and minimal residual disease (MRD)-negativity compared to a commonly used standard of care obinutuzumab plus chlorambucil. |
| 2019-05-16 | Hoffmann-La Roche | Regulatory Roche announces FDA approval for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukaemia roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) for the treatment of people with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). |
| 2019-05-16 | AstraZeneca | Results AstraZeneca continues to redefine cancer treatment at the 2019 ASCO Annual Meeting astrazeneca.com ↗
Three-year results from the Phase Ib/II ACE-CL-003 trial evaluating Calquence and obinutuzumab in treatment-naïve and previously-treated CLL (Abstract #7500) |
| 2019-05-15 | Genentech, Inc. | Regulatory Genentech Announces FDA Approval for Venclexta plus Gazyva for People With Previously Untreated Chronic Lymphocytic Leukemia gene.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). |
| 2019-05-15 | AbbVie | Regulatory AbbVie Announces US FDA Approval of VENCLEXTA® (venetoclax) as a Chemotherapy-Free Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia Patients abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved VENCLEXTA® (venetoclax) in combination with obinutuzumab (GAZYVA®) for previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). |
| 2019-03-07 | Hoffmann-La Roche | Regulatory Roche submits supplemental new drug application to FDA for Venclexta plus Gazyva for previously untreated chronic lymphocytic leukaemia with co-existing medical conditions roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the submission of a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) in people with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions. |
| 2019-03-07 | Genentech, Inc. | Regulatory Genentech Submits Supplemental New Drug Application to FDA for Venclexta Plus Gazyva for Previously Untreated Chronic Lymphocytic Leukemia with Co-Existing Medical Conditions gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. |
| 2019-01-28 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves IMBRUVICA® (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia jnj.com ↗ |
| 2019-01-28 | AbbVie | Regulatory AbbVie Announces U.S. FDA Approval of IMBRUVICA® (ibrutinib) Plus Obinutuzumab (GAZYVA®) - First Chemotherapy-Free, Anti-CD20 Combination Regimen Approved for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) in Previously Untreated Patients abbvie.com ↗
This latest IMBRUVICA FDA approval gives the healthcare community the first chemotherapy-free, anti-CD20 combination to treat CLL and SLL patients who have not yet started therapy. |
| 2018-12-03 | Janssen Research & Development, LLC | Results IMBRUVICA® (ibrutinib) Plus Obinutuzumab Showed Significant Improvement in Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma jnj.com ↗ |
| 2018-12-03 | AbbVie | Results IMBRUVICA® (ibrutinib) Phase 3 Combination Data with Obinutuzumab Finds Significant Improvement in Progression-Free Survival (PFS) Over Standard Chemoimmunotherapy of Chlorambucil Plus Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) abbvie.com ↗ |
| 2018-11-01 | Hoffmann-La Roche | Results Roche to present new data from its industry-leading haematology portfolio at the American Society of Hematology 2018 Annual Meeting roche.com ↗
Data from the phase III GALLIUM study of Gazyva®/Gazyvaro® (obinutuzumab) in previously untreated follicular lymphoma which support the prognostic value of minimal residual disease status at the end of induction treatment will also be presented. |
| 2018-11-01 | Hoffmann-La Roche | Results Phase III data showed that Venclexta/Venclyxto plus Gazyva/Gazyvaro reduced the risk of disease worsening or death in people with previously untreated chronic lymphocytic leukaemia with co-morbidities roche.com ↗ |
| 2018-10-31 | Genentech, Inc. | Results Phase III Data Showed That Venclexta Plus Gazyva Reduced The Risk Of Disease Worsening Or Death In People With Previously Untreated Chronic Lymphocytic Leukemia With Co-Morbidities gene.com ↗
Phase III Data Showed That Venclexta Plus Gazyva Reduced The Risk Of Disease Worsening Or Death In People With Previously Untreated Chronic Lymphocytic Leukemia With Co-Morbidities |
| 2018-10-31 | AbbVie | Results AbbVie Announces Positive Results from CLL14, a Phase 3 Trial Evaluating a Venetoclax Combination as First-Line Therapy with a Fixed Duration of Treatment in Patients with Chronic Lymphocytic Leukemia abbvie.com ↗
The study met its primary endpoint of investigator-assessed progression-free survival (PFS; the time on treatment without disease progression or death 1 ) with a 12-month fixed duration of treatment. |
| 2018-10-17 | AbbVie | Regulatory AbbVie Announces Supplemental New Drug Application Accepted for Priority Review by U.S. FDA for IMBRUVICA® (ibrutinib) in Combination with Obinutuzumab (GAZYVA®) for Previously Untreated Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗ |
| 2018-07-02 | Chugai Pharmaceutical | Regulatory Humanized Anti-CD20 Monoclonal Antibody, “GAZYVA ® Intravenous Infusion 1000 mg,” Approved for the Treatment of CD20-Positive Follicular Lymphoma chugai-pharm.co.jp ↗ |
| 2018-06-15 | Hoffmann-La Roche | Results New long-term data confirm Roche's Gazyva/Gazyvaro extends the lives of people with chronic lymphocytic leukaemia compared to MabThera/Rituxan roche.com ↗
After a follow-up of nearly five years, final results showed clinically meaningful improvements with Gazyva/Gazyvaro plus chlorambucil across multiple endpoints, including progression-free survival (PFS) and overall survival (OS), when compared head-to-head with MabThera®/Rituxan® (rituximab) plus chlorambucil. |
| 2018-05-24 | AbbVie | Results IMBRUVICA® (ibrutinib) Plus GAZYVA® (obinutuzumab) Phase 3 iLLUMINATE Trial for First-Line Therapy of Chronic Lymphocytic Leukemia (CLL) Patients Met Primary Endpoint abbvie.com ↗
Specifically, the study met its primary endpoint for a clinically and statistically significant difference in PFS for patients treated with IMBRUVICA plus obinutuzumab versus those who received chlorambucil plus obinutuzumab, as assessed by an Independent Review Committee (IRC). |
| 2017-12-09 | BeOne Medicines | Results BeiGene Presents Updated Preliminary Phase 1b Data on BTK Inhibitor Zanubrutinib (BGB-3111) Combined with GAZYVA® (Obinutuzumab) at the 59th American Society of Hematology Annual Meeting beonemedicines.com ↗
The updated preliminary Phase 1b data demonstrated that the combination was generally well tolerated and was highly active in patients with FL and treatment-naïve (TN) or relapsed or refractory (R/R) CLL/SLL. |
| 2017-12-06 | AstraZeneca | Results AstraZeneca to highlight its commitment to blood cancers at the 2017 American Society of Hematology Annual Meeting astrazeneca.com ↗
Results will be presented from the Phase Ib/II ACE-CL-003 trial evaluating Calquence and obinutuzumab in treatment-naïve and previously-treated CLL patients (Abstract #432 ), which highlight the safety profile and activity of the combination. |
| 2017-11-17 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Gazyva for previously untreated advanced follicular lymphoma roche.com ↗
With this approval, Gazyva is available in the US for three different indications across two common types of blood cancer. |
| 2017-11-16 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Gazyva for Previously Untreated Advanced Follicular Lymphoma gene.com ↗
FDA Approves Genentech’s Gazyva for Previously Untreated Advanced Follicular Lymphoma |
| 2017-09-22 | Hoffmann-La Roche | Regulatory Roche receives EU approval of Gazyvaro for people with previously untreated advanced follicular lymphoma roche.com ↗ |
| 2017-08-27 | Genentech, Inc. | Regulatory FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma gene.com ↗
FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma |
| 2017-08-23 | Chugai Pharmaceutical | Regulatory New Drug Application Filed for Glycoengineered Type II Anti-CD20 Monoclonal Antibody, Obinutuzumab chugai-pharm.co.jp ↗
I am very glad that a new drug application for our co-developed product, obinutuzumab, was filed. |
| 2017-07-21 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Gazyvaro for people with previously untreated advanced follicular lymphoma roche.com ↗ |
| 2017-06-23 | Hoffmann-La Roche | Results Roche presents new data from GALLIUM study reinforcing clinical benefit of Gazyva/Gazyvaro in people with previously untreated follicular lymphoma roche.com ↗
The data confirmed that the improvement in progression-free survival (PFS) with Gazyva®/Gazyvaro® (obinutuzumab)-based treatment over MabThera®/Rituxan®(rituximab)-based treatment was sustained in an updated analysis with a further six months of follow-up, irrespective of chemotherapy regimen. |
| 2017-06-16 | BeOne Medicines | Results BeiGene Presents Initial Phase 1 Data on BTK Inhibitor BGB-3111 Combined with Obinutuzumab at the 14th International Conference on Malignant Lymphoma and Announces Additional Planned Global Registrational Trials for BGB-3111 beonemedicines.com ↗
The preliminary clinical results to date suggest that the combination is well tolerated and highly active in patients with CLL or SLL and FL. |
| 2016-12-05 | Hoffmann-La Roche | Results Roche’s Gazyva/Gazyvaro Helped People With Previously Untreated Follicular Lymphoma Live Significantly Longer Without Their Disease Worsening Compared to MabThera/Rituxan roche.com ↗
The results showed Gazyva/Gazyvaro-based treatment reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator) by 34 percent compared to MabThera/Rituxan-based treatment (HR=0.66; 95% CI 0.51-0.85, p=0.0012). |
| 2016-12-04 | Genentech, Inc. | Results Genentech’s Gazyva Helped People With Previously Untreated Follicular Lymphoma Live Significantly Longer without their Disease Worsening Compared to Rituxan gene.com ↗
The results showed Gazyva-based treatment reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator) by 34 percent compared to Rituxan-based treatment (HR=0.66; 95% CI 0.51-0.85, p=0.0012). |
| 2016-11-03 | Hoffmann-La Roche | Results Roche showcases new clinical data across a variety of blood diseases at American Society of Hematology 2016 Annual Meeting roche.com ↗
We are excited to share the results of the pivotal GALLIUM study in previously untreated follicular lymphoma, which showed that people treated with Gazyva/Gazyvaro plus chemotherapy lived significantly longer without their disease worsening than those treated with Rituxan/MabThera plus chemotherapy. |
| 2016-11-03 | Genentech, Inc. | Results Genentech Showcases New Clinical Data Across a Variety of Blood Diseases at American Society of Hematology 2016 Annual Meeting gene.com ↗
We are excited to share the results of the pivotal GALLIUM study in previously untreated follicular lymphoma, which showed that people treated with Gazyva plus chemotherapy lived significantly longer without their disease worsening than those treated with Rituxan plus chemotherapy. |
| 2016-07-19 | Nippon Shinyaku Co., Ltd. | Results 糖鎖改変型タイプⅡ抗CD20モノクローナル抗体オビヌツズマブ （開発記号：GA101）の海外第Ⅲ相臨床試験(GOYA試験)結果に関するお知らせ nippon-shinyaku.co.jp ↗
Gazyva/GazyvaroとCHOP療法の併用とMabThera/RituxanとCHOP療法の併用を比較したGOYA試験で、主要評価項目である無増悪生存期間の延長は未達 |
| 2016-07-18 | Hoffmann-La Roche | Results Roche provides update on phase III study of Gazyva/Gazyvaro in people with previously untreated diffuse large B-cell lymphoma roche.com ↗
GOYA study did not meet its primary endpoint of improvement in progression-free survival with Gazyva/Gazyvaro plus CHOP chemotherapy versus MabThera/Rituxan plus CHOP chemotherapy |
| 2016-07-17 | Genentech, Inc. | Results Genentech Provides Update on Phase III Study of Gazyva® in People with Previously Untreated Diffuse Large B-Cell Lymphoma gene.com ↗
GOYA study did not meet its primary endpoint of improvement in progression-free survival with Gazyva plus CHOP chemotherapy versus Rituxan plus CHOP chemotherapy |
| 2016-06-16 | Hoffmann-La Roche | Regulatory Roche's Gazyvaro approved in Europe in combination with bendamustine for people with previously treated follicular lymphoma roche.com ↗ |
| 2016-05-27 | Hoffmann-La Roche | Results Roche’s Gazyva/Gazyvaro showed superior progression-free survival compared to MabThera/Rituxan in people with previously untreated follicular lymphoma roche.com ↗
Results from a pre-planned interim analysis showed that Gazyva/Gazyvaro-based treatment significantly reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator) compared to MabThera/Rituxan-based treatment. |
| 2016-05-27 | Nippon Shinyaku Co., Ltd. | Results 糖鎖改変型タイプⅡ抗CD20モノクローナル抗体オビヌツズマブ （開発記号：GA101）の海外第Ⅲ相臨床試験結果に関するお知らせ nippon-shinyaku.co.jp ↗
ロシュ社は本日、未治療の濾胞性リンパ腫の患者さんを対象とした主要な第III相臨床試験であるGALLIUM試験において、良好な成績が得られたことを発表しました。 |
| 2016-05-26 | Genentech, Inc. | Results Genentech’s Gazyva® Showed Superior Progression-Free Survival Compared to Rituxan® in People with Previously Untreated Follicular Lymphoma gene.com ↗
Results from a pre-planned interim analysis showed that Gazyva-based treatment significantly reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator) compared to Rituxan-based treatment. |
| 2016-04-29 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Gazyvaro for people with previously treated follicular lymphoma roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Gazyvaro® (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyvaro maintenance as a new treatment for people with follicular lymphoma who did not respond to, or who progressed during or up to six months after treatment with MabThera® (rituximab) or a MabThera-containing regimen. |
| 2016-02-29 | Hoffmann-La Roche | Regulatory FDA approves Roche's Gazyva (obinutuzumab) for certain people with previously treated follicular lymphoma roche.com ↗ |
| 2016-02-26 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Gazyva (Obinutuzumab) for Certain People with Previously Treated Follicular 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) approved Gazyva®(obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan® (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment. |
| 2015-12-05 | Genentech, Inc. | Results New Results from CLL11 Study Show Gazyva® Provided People with Previously Untreated Chronic Lymphocytic Leukemia a Treatment-free Period of Nearly Four Years gene.com ↗
New Results from CLL11 Study Show Gazyva® Provided People with Previously Untreated Chronic Lymphocytic Leukemia a Treatment-free Period of Nearly Four Years |
| 2015-11-05 | Genentech, Inc. | Regulatory Genentech to Present New Clinical Data Across a Variety of Blood Diseases at American Society of Hematology 2015 Annual Meeting gene.com ↗
Gazyva marketing applications submitted to health authorities based on GADOLIN study results; priority review granted by the U.S. Food and Drug Administration |
| 2015-05-30 | Genentech, Inc. | Results Genentech’s Gazyva® Extended the Time People with Refractory Indolent Non-Hodgkin’s Lymphoma Lived Without Their Disease Worsening gene.com ↗
In the study, Gazyva plus bendamustine followed by Gazyva alone reduced the risk of disease worsening or death (progression-free survival, PFS) by 45 percent (HR=0.55, p=0.0001), compared to bendamustine alone. |
| 2015-02-03 | Genentech, Inc. | Results Genentech’s Phase III Study of Gazyva® Showed Significant Benefit in Refractory Indolent Non-Hodgkin’s Lymphoma gene.com ↗
The study showed that people lived significantly longer without disease worsening or death (progression-free survival; PFS) when treated with Gazyva (obinutuzumab) plus bendamustine followed by Gazyva alone, compared to bendamustine alone. |
All press releases naming this drug 150 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 150 releases opens the full record — a long page | ||
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 327 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OBINUTUZUMAB | “Targeting Bruton's tyrosine kinase (BTK), the novel BTK inhibitor zanubrutinib (highly selective, low toxicity) combined with obinutuzumab (enhanced antibody-dependent...” NCT07165769 ↗312“Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL” NCT03836261 ↗ “Obinutuzumab 1000 mg will be administered once by intravenous infusion on Cycle 1 Day 1 as pretreatment before glofitamab administration” NCT07702851 ↗ “Obinutuzumab is a type II anti-CD20 monoclonal antibody that enhances antibody-dependent cellular cytotoxicity better than rituximab.” PMID 30068505 ↗ Aug 2018 “either Rituximab 375mg/m², intravenous infusion, Day 1 of each cycle, C1-C6; or Obinutuzumab 1000mg, intravenous infusion” NCT07355699 ↗ “2. Obinutuzumab: 1000mg intravenously on days 1, 8, and 15 of cycle 1 and on day 1 of subsequent 5 cycles;” NCT06918015 ↗ “Two doses of 1,000 mg IV obinutuzumab given prior to starting pembrolizumab and naptumomab estafenatox” NCT05894447 ↗ “The type II anti-CD20 antibody Obinutuzumab (OBINUTUZUMAB) has demonstrated remarkable activity” NCT03322865 ↗ “A single dose of obinutuzumab 1000 mg will be administered intravenously on Day 1 of Cycle 1.” NCT07012980 ↗ “Patients will receive obinutuzumab 1000mg IV (cycle 1: day 1,8,15; Cycle2-6: day1)” NCT05478512 ↗ “Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints.” NCT03039114 ↗ |
| Known as | AFUTUZUMAB | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743048 ↗ |
| Known as | GA101 | “This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab [RO5072759 (GA101)] in combination with CHOP (Cyclophosphamide, Doxorubicin,...” NCT01414855 ↗18“Phase II Single-arm "Window-of-opportunity" Study of a Combination of Obinutuzumab (GA-101) and Venetoclax (ABT-199) in Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)” NCT02987400 ↗ “Obinutuzumab (GA 101) is a first-in-class, potent, intravenously administered type II anti-CD 20 antibody that is developed by Roche AG for the treatment of B-cell malignancies.” NCT03492775 ↗ “Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL” NCT03836261 ↗ “The CLL11 trial revealed an impressive improvement in efficacy with GA-101 (obinutuzumab) as compared to rituximab when combined with Chlorambucil.” NCT02758665 ↗ “Obinutuzumab (GA101) is a type II, glycoengineered anti-CD20 monoclonal antibody for the treatment of hematologic malignancies.” PMID 26659915 ↗ Dec 2015 “fixed doses of obinutuzumab (GA101) in relapsed/refractory follicular lymphoma patients” NCT01582776 ↗ “GA101 - Obinutuzumab by IV infusion” NCT02229422 ↗ “GA101 (Obinutuzumab)” NCT02320383 ↗ |
| Known as | GA101 : Obinutuzumab | “GA101 : Obinutuzumab” NCT02558816 ↗ |
| Known as | GAZYVA | “Experimental: GAZYVA, GAZYVARO(Obinutuzumab)” NCT05050214 ↗5“Obinutuzumab Injection [Gazyva]” NCT03341520 ↗ “Obinutuzumab Injection [Gazyva]” NCT05995054 ↗ “Obinutuzumab Injection [Gazyva]” NCT06094881 ↗ “Obinutuzumab 25 MG/ML [Gazyva]” NCT04082897 ↗ “Gazyva” NCT04189588 ↗ |
| Known as | Gazyvaro | “Obinutuzumab (Gazyvaro®) Obinutuzumab is a humanized glycoengineered type II anti-CD20 monoclonal antibody that recognizes the CD20 antigen present on normal and malignant B...” NCT06186648 ↗1“Experimental: GAZYVA, GAZYVARO(Obinutuzumab)” NCT05050214 ↗ |
| Known as | HUMAB CD20 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743048 ↗ |
| Known as | OBI | “Obinutuzumab (OBI), a next-generation fully humanized anti-CD20 monoclonal antibody” NCT07163611 ↗ |
| Known as | Obinutuzumab: Gazyva | “Obinutuzumab: Gazyva” NCT02100852 ↗ |
| Known as | OBZ | “Obinutuzumab (OBZ) is a type II anti-CD20 monoclonal antibody with a glycomodified Fc, approved in 2013 for the treatment of chronic lymphocytic leukemia.” NCT07268521 ↗ |
| Known as | R-7159 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743048 ↗ |
| Known as | RG-7159 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743048 ↗ |
| Known as | RO 5072759 HUMAB<CD20> | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743048 ↗ |
| Known as | RO5072759 | “This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab [RO5072759 (GA101)] in combination with CHOP (Cyclophosphamide, Doxorubicin,...” NCT01414855 ↗1“A Study of Obinutuzumab (RO5072759) Induction in Patients With Relapsed/ Refractory Waldenström Macroglobulinemia, OBI-1” NCT03679455 ↗ |
| Action | Inhibit | “anti-CD20 monoclonal antibody” PMID 31050355 ↗ Jul 2019 |
| Modality | Monoclonal antibody | “Obinutuzumab (GA101) is a type II, glycoengineered anti-CD20 monoclonal antibody for the treatment of hematologic malignancies.” PMID 26659915 ↗ Dec 2015 |
| Route | Intravenous | “via intravenous infusion of obinutuzumab” NCT00517530 ↗ |
| Target | MS4A1 | “B-lymphocyte antigen CD20 binding agent” CHEMBL1743048 ↗ |