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.
Extravasation: no information
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Diseases for which it is used
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