Obinutuzumab (Gazyva)

==General information==
Class/mechanism: Glyco-engineered anti-CD20 IgG1 type II monoclonal antibody. Engineered with a modified elbow hinge residue (valine instead of leucine at Kabat position 11) and a glyco-engineered Fc region, which is postulated to enhance its immunomodulatory effect.Obinutuzumab (Gazyva) package insertObinutuzumab (Gazyva) package insert (locally hosted backup)Gazyva manufacturer's website
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the package insert.
==Diseases for which it is established==
*Chronic lymphocytic leukemia (EMA, FDA)
*Indolent lymphoma
**Follicular lymphoma (EMA, FDA, PMDA)
==Diseases for which it is used==
*Diffuse large B-cell lymphoma
*Mantle cell lymphoma
==Patient drug information==
*Obinutuzumab (Gazyva) package insert
*Obinutuzumab (Gazyva)patient drug information (Chemocare)Obinutuzumab (Gazyva)patient drug information (Chemocare)
*Obinutuzumab (Gazyva)patient drug information (UpToDate)Obinutuzumab (Gazyva)patient drug information (UpToDate)
==History of changes in FDA indication==
===Chronic lymphocytic leukemia===
*2013-11-01: Granted FDA approval for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). (Based on GCLLSG CLL11)
===Follicular lymphoma===
*2016-02-26: FDA approval expanded for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. (Based on GADOLIN)
*2017-11-16: Granted regular FDA approval in combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma (FL). (Based on GALLIUM)
==History of changes in EMA indication==
*2014-07-22: Initial authorization as Gazyvaro for the treatment in combination with chlorambucil of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy. (Based on GCLLSG CLL11)
*2016-06-13: Extension of indication to add the treatment of patients with follicular lymphoma. (Based on GADOLIN)
*2017-09-18: Extension of Indication to include a new indication for Gazyvaro in combination with chemotherapy for the treatment of patients with previously untreated advanced follicular lymphoma.
*2017-09-18: Extension of Indication to include a new indication for Gazyvaro maintenance therapy in patients achieving a response to Gazyvaro in combination with chemotherapy, for the treatment of patients with previously untreated advanced follicular lymphoma.
==History of changes in Health Canada indication==
*2014-11-25: Initial notice of compliance
==History of changes in PMDA indication==
*2018-07-02: Initial approval for the treatment of CD20-positive follicular lymphoma.
==Also known as==
*Code names: GA-101, R-7159, RO-5072759
*Generic name: afutuzumab
*Brand name: Gazyva, Gazyvaro
==References==
Category:Drugs
Category:Intravenous medications
Category:Anti-CD20 antibodies
Category:Chronic lymphocytic leukemia medications
Category:Diffuse large B-cell lymphoma medications
Category:Follicular lymphoma medications
Category:Indolent lymphoma medications
Category:Mantle cell lymphoma medications
Category:FDA approved in 2013
Category:EMA approved in 2014
Category:Health Canada approved in 2014
Category:PMDA approved in 2018