Difference between revisions of "Obinutuzumab (Gazyva)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *11/1/2013: Granted FDA [http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#breakthrough breakthrough therapy] designation for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL) | + | *11/1/2013: Granted FDA [http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#breakthrough breakthrough therapy] designation for use in combination with [[Chlorambucil (Leukeran) | chlorambucil]] for the treatment of patients with previously untreated [[Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL) | chronic lymphocytic leukemia (CLL)]]. |
==Also known as== | ==Also known as== | ||
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<references/> | <references/> | ||
| + | [[Category:Drug index]] | ||
| + | [[Category:Chemotherapy]] | ||
| + | [[Category:Intravenous chemotherapy]] | ||
| + | |||
| + | [[Category:Immunotherapy]] | ||
[[Category:Antibody medications]] | [[Category:Antibody medications]] | ||
| + | [[Category:Anti-CD20 medications]] | ||
[[Category:Aggressive Non-Hodgkin lymphoma medications]] | [[Category:Aggressive Non-Hodgkin lymphoma medications]] | ||
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[[Category:Follicular lymphoma medications]] | [[Category:Follicular lymphoma medications]] | ||
[[Category:Mantle cell lymphoma medications]] | [[Category:Mantle cell lymphoma medications]] | ||
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| + | [[Category:Drugs FDA approved in 2013]] | ||
Revision as of 23:57, 13 November 2014
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]
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
- Mantle cell 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.
References
- ↑ Reichert JM. Antibody-based therapeutics to watch in 2011. MAbs. 2011 Jan-Feb;3(1):76-99. Epub 2011 Jan 1. link to original article PubMed
- Drug index
- Chemotherapy
- Intravenous chemotherapy
- Immunotherapy
- Antibody medications
- Anti-CD20 medications
- Aggressive Non-Hodgkin lymphoma medications
- Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL) medications
- Follicular lymphoma medications
- Mantle cell lymphoma medications
- Drugs FDA approved in 2013