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.
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.

Diseases for which it is used

• Chronic lymphocytic leukemia (CLL/SLL)
• Diffuse large B-cell lymphoma
• Follicular lymphoma
• Mantle cell lymphoma

Patient drug information

No information available.

History of changes in FDA indication

• 11/1/2013: Granted FDA approval for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
• 2/26/2016: 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."
• 11/16/2017: 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)."

Also known as

• Code names: GA101, R7159, RO5072759
• Generic name: afutuzumab
• Brand name: Gazyva