Obinutuzumab (Gazyva)

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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, 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

Follicular lymphoma

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

Also known as

  • Code names: GA-101, R-7159, RO-5072759
  • Generic name: afutuzumab
  • Brand name: Gazyva, Gazyvaro