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Synonyms: GA-101 | GA101 | Gazyva®
obinutuzumab is an approved drug (FDA (2013), EMA (2014))
Compound class:
Antibody
Comment: Obinutuzumab is a third-generation, humanized and glyco-engineered anti-CD20 IgG1 mAb. Prior to 2009 obinutuzumab was known as afutuzumab.
Annotated peptide sequences for this antibody are available from its IMGT/mAb-DB record. 
View more information in the IUPHAR Pharmacology Education Project: obinutuzumab |
| No information available. |
Summary of Clinical Use  |
| Initially approved to treat chronic lymphocytic leukemia (CLL) in combination with chemotherapy in patients who have received no prior therapy. In November 2012, this antibody was authorised as an orphan drug by the EMA for the treatment of CLL. Full EMA approval for CLL was granted in July 2014. In February 2016, the US FDA expanded approval to include treatment of patients with follicular lymphoma (FL) who have relapsed after, or are refractory to, a rituximab-containing regimen. This new approval is for a combination therapy of obinutuzumab with bendamustine, followed by obinutuzumab monotherapy. In September 2019 the FDA granted Breakthrough Therapy Designation as a treatment for lupus nephritis, a chronic autoimmune condition for which there is no currently FDA-approved drug. Results from Phase 2 trial NCT02550652 (NOBILITY study) led to this designation. Obinutuzumab (plus standard of care) demonstrated enhanced efficacy compared to placebo plus standard of care in achieving complete renal response [2-3,6]. |
| Mechanism Of Action and Pharmacodynamic Effects |
| Obinutuzumab acts as an immunomodulator by targeting CD20 and killing B cells. |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT02550652 | A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN) | Phase 2 Interventional | Hoffmann-La Roche | ||
| NCT05039619 | 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 | Phase 2 Interventional | Hoffmann-La Roche | ||
| NCT04221477 | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis | Phase 3 Interventional | Hoffmann-La Roche | ||
| NCT04702256 | Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF | Phase 3 Interventional | Assistance Publique - Hôpitaux de Paris | ||
| External links |
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For extended ADME data see the following: Electronic Medicines Compendium (eMC) Drugs.com European Medicines Agency (EMA) |
