Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 136 |
| INN | Obinutuzumab |
| Status | Approved |
| Drug code(s) | RO5072759, GA101, RG7159 |
| Brand name | Gazyva |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD20 |
| Indications of clinical studies | Diffuse Large B Cell Lymphoma, Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 15, 2007 |
| Start of Phase 2 | |
| Start of Phase 3 | December 21, 2009 |
| Date BLA/NDA submitted to FDA | April 22, 2013 |
| Year of first approval (global) | 2013 |
| Date of first US approval | November 01, 2013 |
| INN, US product name | Obinutuzumab |
| US or EU approved indications | Chronic Lymphocytic Leukemia /Small Cell Lymphocytic Lymphoma, Indolent Non-Hodgkin's Lymphoma; combination ibrutinib obinutuzumab approved by the FDA for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma. |
| Company | Genentech |
| Licensee/Partner | None |
| Comments about company or candidate | Approved in the US in 2013, EU in 2014 Breakthrough Therapy designation from FDA announced in May 2013; BLA submitted in May 2013; priority review; Approved November 1, 2013. NCT01010061 Phase 3 started in Dec 2009. NCT00517530 Phase 1 started in Sep 2007. |
| Full address of company | South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us |
GlycoMab technology; increased effector function. INN was formerly afutuzumab
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |