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Obinutuzumab

Generic Name
Obinutuzumab
Brand Names
Gazyva, Gazyvaro
Drug Type
Biotech
Chemical Formula
-
CAS Number
949142-50-1
Unique Ingredient Identifier
O43472U9X8
Background

Obinutuzumab is a humanized monoclonal antibody used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia. It was approved by the FDA in November 2013 and is marketed under the brand name Gazyva. There is a black box warning of fatal Hepatitis B Virus (HBV) reactivation and fatal Progressive Multifocal Leukoencephalopathy (PML).

Indication

Obinutuzumab is used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia.

Associated Conditions
Refractory Follicular Lymphoma, Previously untreated Chronic lymphocytic leukemia
Associated Therapies
-
Clinical Trials
Related News

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)

Phase 3
Completed
Conditions
Lymphocytic Leukemia, Chronic
Interventions
Drug: obinutuzumab
Drug: chlorambucil
Drug: rituximab
First Posted Date
2009-11-09
Last Posted Date
2018-09-14
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
787
Registration Number
NCT01010061

A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma

First Posted Date
2009-01-19
Last Posted Date
2016-11-04
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
137
Registration Number
NCT00825149

A Dose-Escalating Study of Obinutuzumab in Patients With B-lymphocyte Antigen (CD20+) Malignant Disease (GAUGUIN)

Phase 1
Completed
Conditions
Lymphoma
Interventions
Drug: Obinutuzumab
First Posted Date
2007-08-17
Last Posted Date
2016-10-11
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
134
Registration Number
NCT00517530
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