CHMP recommends EU approval of Roche’s Gazyva/Gazyvaro for lupus nephritis
Roche (OTCQX:RHHBY) announced that the European Medicines Agency's CHMP has recommended approval of Gazyva/Gazyvaro (obinutuzumab) with mycophenolate mofetil for adults with active Class III or IV lupus nephritis, with or without Class V. A European Commission decision is pending.
Recommendation is based on phase II NOBILITY and phase III REGENCY data: 46.4% of patients on Gazyva plus standard therapy achieved complete renal response versus 33.1% on standard therapy alone, with a significant reduction in corticosteroid use and improved proteinuric response. Safety was consistent with known haematology-oncology profile. An FDA decision is expected later this year.
Roche (OTCQX:RHHBY) ha annunciato che il CHMP dell'Agenzia europea per i medicinali ha raccomandato l'approvazione di Gazyva/Gazyvaro (obinutuzumab) con mofetil micofenolato per adulti con lupus nefritico attivo di classe III o IV, con o senza classe V. Una decisione della Commissione Europea è in attesa.
La raccomandazione si basa sui dati di fase II NOBILITY e fase III REGENCY: 46,4% dei pazienti trattati con Gazyva più terapia standard hanno ottenuto una risposta renale completa rispetto al 33,1% con la terapia standard da sola, con una significativa riduzione dell'uso di corticosteroidi e un miglioramento della risposta proteica. La sicurezza è risultata coerente con il profilo ematologico-oncologico noto. Una decisione FDA è attesa per quest'anno.
Roche (OTCQX:RHHBY) anunció que el CHMP de la Agencia Europea de Medicamentos ha recomendado la aprobación de Gazyva/Gazyvaro (obinutuzumab) con mofetil micofenolato para adultos con lupus nefritis activa de clases III o IV, con o sin clase V. Se espera una decisión de la Comisión Europea.
La recomendación se basa en los datos de las fases II NOBILITY y III REGENCY: 46,4% de los pacientes con Gazyva más terapia estándar lograron una respuesta renal completa frente al 33,1% con solo la terapia estándar, con una reducción significativa en el uso de corticosteroides y una mejor respuesta proteínica. La seguridad fue consistente con el perfil hematológico-oncológico conocido. Se espera una decisión de la FDA para más tarde este año.
로체(OTCQX:RHHBY)가 유럽 의약품청(CHMP)이 성인 활성 Class III 또는 IV 루푸스 신염, Class V 유무에 관계없이 Gazyva/Gazyvaro(obinutuzumab)를 미코페놀레이트 모펙틸과 함께 승인하도록 권고했다고 발표했습니다. 유럽 위원회의 결정이 보류 중입니다.
권고는 2상 NOBILITY와 3상 REGENCY 데이터에 기반합니다: 46.4%의 Gazyva와 표준 치료를 받은 환자들이 완전 신장 반응을 달성했고 표준 치료 단독의 33.1%와 비교되며, 코르티코스테로이드 사용의 현저한 감소와 단백뇨 반응의 개선이 나타났습니다. 안전성은 알려진 혈액종양 프로필과 일관되었습니다. 이번 해 말 FDA 결정이 예상됩니다.
Roche (OTCQX:RHHBY) a annoncé que le CHMP de l'Agence européenne des médicaments a recommandé l'approbation de Gazyva/Gazyvaro (obinutuzumab) associée au mofétil mofétile chez les adultes atteints de néphrite lupique active de classe III ou IV, avec ou sans classe V. Une décision de la Commission européenne est en attente.
La recommandation est basée sur les données des phases II NOBILITY et III REGENCY: 46,4% des patients sous Gazyva plus thérapie standard ont obtenu une réponse rénale complète par rapport à 33,1% sous thérapie standard seule, avec une réduction significative de l'utilisation des corticostéroïdes et une amélioration de la réponse protéinurique. La sécurité était conforme au profil connu hématologique-oncologique. Une décision de la FDA est attendue plus tard cette année.
Roche (OTCQX:RHHBY) gab bekannt, dass der CHMP der Europäischen Arzneimittel-Agentur die Zulassung von Gazyva/Gazyvaro (Obinutuzumab) in Kombination mit Mycophenolat-Mofetil für erwachsene Patienten mit aktiver Klassen-III- oder IV-Lupusnephritis, mit oder ohne Klasse-V, empfohlen hat. Eine Entscheidung der Europäischen Kommission steht aus.
Die Empfehlung stützt sich auf die Phase-II-NOBILITY- und Phase-III-REGENCY-Daten: 46,4% der Patienten unter Gazyva plus Standardtherapie erzielten eine vollständige renale Reaktion gegenüber 33,1% unter Standardtherapie allein, mit einer signifikanten Reduktion der Kortikosteroid-Nutzung und einer verbesserten proteinarmer Reaktion. Die Sicherheit war konsistent mit dem bekannten hämatologisch-onkologischen Profil. Eine FDA-Entscheidung wird später in diesem Jahr erwartet.
روش (OTCQX:RHHBY) أعلنت أن لجنة CHMP التابعة لهيئة الدواء الأوروبية قد أوصت بالموافقة على Gazyva/Gazyvaro (obinutuzumab) مع ميفوفولات الميفيل للبالغين المصابين بالتهاب الكلية الذاتي النشط من الفئة III أو IV، مع أو بدون الفئة V. القرار من اللجنة الأوروبية في انتظار.
تعتمد التوصية على بيانات المرحلتين II NOBILITY و III REGENCY: 46.4% من المرضى الذين تلقوا Gazyva مع العلاج القياسي حققوا استجابة كلية كلية كاملة مقارنة بـ 33.1% فقط مع العلاج القياسي وحده، مع انخفاض كبير في استخدام الكورتيكوستيرويدات وتحسن في الاستجابة عند البروتينات. السلامة كانت متوافقة مع الملف الهيماتولوجي-السرطاني المعروف. من المتوقع أن يكون قرار FDA في وقت لاحق من هذا العام.
罗氏（OTCQX:RHHBY） 宣布，欧洲药品管理局（EMA） 的 CHMP 已建议批准 Gazyva/Gazyvaro (obinutuzumab) 与霉酚酸甲酯用于成人活动性 III 级或 IV 级狼疮性肾炎（可伴或不伴 V 级）。欧洲委员会的决定尚在等待。
该建议基于 II 期 NOBILITY 与 III 期 REGENCY 数据：46.4% 的患者在 Gazyva 加标准治疗下达到完全肾脏反应，相较于仅接受标准治疗的 33.1%，并且显著减少了皮质类固醇的使用、改善蛋白尿反应。安全性与已知的血液肿瘤特征一致。FDA 的决定预计在今年晚些时候公布。
- Complete renal response 46.4% with Gazyva vs 33.1% control
- Statistically significant reduction in corticosteroid use
- Improved proteinuric response reported in REGENCY
- Only anti-CD20 to show phase III CRR benefit in lupus nephritis
- European Commission final approval is still pending
- US FDA decision expected later in the year (not yet approved)
- Indication limited to adult Class III/IV ± Class V lupus nephritis
- Positive recommendation based on phase II NOBILITY and phase III REGENCY data showing Gazyva/Gazyvaro’s superiority over standard therapy alone1,2
- Gazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study2
- Lupus nephritis is a debilitating condition that severely impacts a person’s quality of life and affects more than 1.7 million people worldwide3,4
Basel, 17 October, 2025 - 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. These disease classifications describe the extent and nature of damage to the kidneys and renal function. A final decision from the European Commission is expected in the near future.
“As the only anti-CD20 to demonstrate a complete renal response benefit in a randomised phase III study of lupus nephritis, Gazyva/Gazyvaro has the potential to address an important unmet need for many people with this disease,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Recognising the challenges faced by people with lupus nephritis and their caregivers, Gazyva/Gazyvaro may offer a new treatment option that can limit kidney damage and potentially prevent or delay end-stage kidney disease.”
The recommendation is based on positive results from the phase II NOBILITY and phase III REGENCY studies. In REGENCY, data showed that nearly half of the participants (
Earlier this year, data from the phase III REGENCY study were used to file a supplemental Biologics License Application with the US Food and Drug Administration (FDA). The FDA is expected to make a decision on approval this year.
Gazyva/Gazyvaro is being investigated in systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and in children and adolescents with lupus nephritis.5-8 In addition to Gazyva/Gazyvaro, Roche has a broad pipeline dedicated to target the immune drivers of rare and common kidney and kidney-related diseases.
About Gazyva/Gazyvaro
Gazyva®/Gazyvaro® (obinutuzumab) is a Type II engineered humanised monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells.9 In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys and reduces their ability to function properly.10 Data suggests that Gazyva/Gazyvaro depletes disease-causing B cells, helping to limit further damage to the kidneys and potentially preventing or delaying progression to end-stage kidney disease.2
Gazyva/Gazyvaro is already approved in 100 countries for various types of haematological cancers. In the United States, Gazyva is part of a collaboration between Genentech and Biogen.
About the REGENCY study
REGENCY [NCT04221477] is a phase III, randomised, double-blind, placebo-controlled, multicentre study investigating the efficacy and safety of Gazyva/Gazyvaro® (obinutuzumab) plus standard therapy (mycophenolate mofetil and glucocorticoids) in people with active/chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V. The study enrolled 271 people, who were randomised 1:1 to receive either Gazyva/Gazyvaro plus standard therapy or placebo plus standard therapy. REGENCY was designed based on robust phase II data and conducted during the COVID-19 pandemic. The study population was representative of the real-world population of people with lupus nephritis.
About lupus nephritis
Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys.11 Lupus nephritis is characterised by an irreversible loss of nephrons, the filtering structures of the kidneys. Periods of intense disease activity, known as flares, can speed up the loss of nephrons and, if left unchecked, may lead to a progressive loss of kidney function. Even with the latest treatments, up to a third of people will progress to end-stage kidney disease within 10 years, where dialysis or transplant are the only options and life expectancy and quality of life are substantially reduced.12
Lupus nephritis affects more than 1.7 million people worldwide - predominantly women, mostly of colour and usually of childbearing age.13 Currently, there is no cure for lupus nephritis.11
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Furie RA, et al. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022 Jan;81(1):100-07.
[2] Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. N Engl J Med. 2025 Feb;392:1471-83.
[3] Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023 Mar;82:351-56.
[4] Bastian HM, et al. Systemic lupus erythematosus in three ethnic groups. XII. Risk factors for lupus nephritis after diagnosis. Lupus. 2002;11(3):152-60.
[5] Clinicaltrials.gov. A study to evaluate the efficacy and safety of obinutuzumab in participants with systemic lupus erythematosus (ALLEGORY). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT04963296.
[6] Clinicaltrials.gov. A study evaluating the efficacy and safety of obinutuzumab in participants with primary membranous nephropathy (MAJESTY). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT04629248.
[7] Clinical trials.gov. A study to evaluate the efficacy and safety of obinutuzumab versus MMF in participants with childhood onset idiopathic nephrotic syndrome (INShore). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT05627557.
[8] Clinicaltrials.gov. A study to evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab in adolescents with active class III or IV lupus nephritis and the safety and PK of obinutuzumab in pediatric participants (POSTERITY). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT05039619.
[9] Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013 Oct;12(10):2031-42.
[10] Atisha-Fregoso Y, et al. Meant to B: B cells as a therapeutic target in systemic lupus erythematosus. J Clin Investig. 2021 Jun 15;131(12):e149095.
[11] Hocaoglu M, et al. Incidence, prevalence, and mortality of lupus nephritis: a population-based study over four decades using the Lupus Midwest Network. Arthritis & Rheumatol 2023 Apr;75(4):567-73.
[12] Mok C, et al. Treatment of lupus nephritis: consensus evidence and perspectives. Nat Rev Rheumatol 2023 Apr;19(4):227-38.
[13] Anders HJ, et al. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7.
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FAQ
What did CHMP recommend for Roche's Gazyva/Gazyvaro (RHHBY) on October 17, 2025?
What were the REGENCY phase III results for Gazyva in lupus nephritis (RHHBY)?
Does the CHMP recommendation mean immediate EU approval for Gazyva (RHHBY)?
How did Gazyva affect steroid use in the REGENCY study for RHHBY?
What is the safety profile of Gazyva/Gazyvaro reported in the lupus nephritis data (RHHBY)?
Will Gazyva (RHHBY) be considered for other kidney diseases?
