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.^[1]^[2]^[3]
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, UpToDate (courtesy of Lexicomp), or the package insert.^[1]

Diseases for which it is established (work in progress)

Diseases for which it is used

Patient drug information

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, followed by Gazyvaro maintenance therapy in patients achieving a response, 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

[insert-1] 1.0 ^1.1 ^1.2 Obinutuzumab (Gazyva) package insert

[2] Obinutuzumab (Gazyva) package insert (locally hosted backup)

[3] Gazyva manufacturer's website

[4] Obinutuzumab (Gazyva)patient drug information (Chemocare)

[5] Obinutuzumab (Gazyva)patient drug information (UpToDate)

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