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

• Aggressive Non-Hodgkin lymphoma
• Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL)
• Follicular lymphoma

Patient drug information

No information available.

History of changes in FDA indication

• 11/1/2013: Granted FDA breakthrough therapy designation for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL)

Also known as

GA101, RO5072759, Afutuzumab.