Difference between revisions of "Obinutuzumab (Gazyva)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Glyco-engineered anti-[http://en.wikipedia.org/wiki/CD20 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.<ref name="insert">[http://www.gene.com/download/pdf/gazyva_prescribing.pdf Obinutuzumab (Gazyva) package insert]</ref><ref>[[ | + | Class/mechanism: Glyco-engineered anti-[http://en.wikipedia.org/wiki/CD20 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.<ref name="insert">[http://www.gene.com/download/pdf/gazyva_prescribing.pdf Obinutuzumab (Gazyva) package insert]</ref><ref>[[:File:Obinutuzumab.pdf|Obinutuzumab (Gazyva) package insert (locally hosted backup)]]</ref><ref>[http://www.gazyva.com/ Gazyva manufacturer's website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the package insert.<ref name="insert"></ref> | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the package insert.<ref name="insert"></ref> | ||
| + | |||
| + | ==Diseases for which it is established ''(work in progress)''== | ||
| + | *[[Chronic lymphocytic leukemia]] | ||
| + | *[[Follicular lymphoma]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | |||
*[[Diffuse large B-cell lymphoma]] | *[[Diffuse large B-cell lymphoma]] | ||
| − | |||
*[[Mantle cell lymphoma]] | *[[Mantle cell lymphoma]] | ||
==Patient drug information== | ==Patient drug information== | ||
| − | + | *[http://www.gene.com/download/pdf/gazyva_prescribing.pdf Obinutuzumab (Gazyva) package insert]<ref name="insert"></ref> | |
| + | *[https://chemocare.com/druginfo/obinutuzumab.aspx Obinutuzumab (Gazyva)patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/obinutuzumab.aspx Obinutuzumab (Gazyva)patient drug information (Chemocare)]</ref> | ||
| + | *[http://www.uptodate.com/contents/obinutuzumab-patient-drug-information Obinutuzumab (Gazyva)patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/obinutuzumab-patient-drug-information Obinutuzumab (Gazyva)patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *11 | + | ===[[Chronic lymphocytic leukemia]]=== |
| − | * | + | *2013-11-01: Granted FDA approval for use [[Chronic_lymphocytic_leukemia_(CLL)_and_Small_lymphocytic_lymphoma_(SLL)#Chlorambucil_.26_Obinutuzumab_.28GClb.29_.28GClb.29|in combination with chlorambucil]] for the treatment of patients with previously untreated [[Chronic lymphocytic leukemia | chronic lymphocytic leukemia (CLL)]]. ''(Based on GCLLSG CLL11)'' |
| − | *11 | + | ===[[Follicular lymphoma]]=== |
| − | + | *2016-02-26: FDA approval expanded for use [[Follicular_lymphoma#Bendamustine_.26_Obinutuzumab|in combination with bendamustine]] followed by [[Follicular_lymphoma#Obinutuzumab_monotherapy_3|obinutuzumab monotherapy]] for the treatment of patients with [[Follicular lymphoma|follicular lymphoma (FL)]] who relapsed after, or are refractory to, a [[Regimen_classes#Rituximab-containing_regimen|rituximab-containing regimen]]. ''(Based on GADOLIN)'' | |
| + | *2017-11-16: 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|follicular lymphoma (FL)]]. ''(Based on GALLIUM)'' | ||
| + | ==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 leukemia|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== | ||
| + | *2018-07-02: Initial approval for the treatment of CD20-positive [[follicular lymphoma]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code names:''' | + | *'''Code names:''' GA-101, R-7159, RO-5072759 |
*'''Generic name:''' afutuzumab | *'''Generic name:''' afutuzumab | ||
| − | *'''Brand name:''' Gazyva | + | *'''Brand name:''' Gazyva, Gazyvaro |
==References== | ==References== | ||
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[[Category:Drugs]] | [[Category:Drugs]] | ||
| − | |||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | |||
| − | |||
[[Category:Anti-CD20 antibodies]] | [[Category:Anti-CD20 antibodies]] | ||
| − | |||
[[Category:Chronic lymphocytic leukemia medications]] | [[Category:Chronic lymphocytic leukemia medications]] | ||
| Line 43: | Line 52: | ||
[[Category:FDA approved in 2013]] | [[Category:FDA approved in 2013]] | ||
| + | [[Category:EMA approved in 2014]] | ||
| + | [[Category:Health Canada approved in 2014]] | ||
| + | [[Category:PMDA approved in 2018]] | ||
Revision as of 11:00, 11 September 2023
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, 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.[1]
Diseases for which it is established (work in progress)
Diseases for which it is used
Patient drug information
- Obinutuzumab (Gazyva) package insert[1]
- Obinutuzumab (Gazyva)patient drug information (Chemocare)[4]
- Obinutuzumab (Gazyva)patient drug information (UpToDate)[5]
History of changes in FDA indication
Chronic lymphocytic leukemia
- 2013-11-01: Granted FDA approval for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). (Based on GCLLSG CLL11)
Follicular lymphoma
- 2016-02-26: 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. (Based on GADOLIN)
- 2017-11-16: 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). (Based on GALLIUM)
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
- 2018-07-02: Initial approval for the treatment of CD20-positive follicular lymphoma.
Also known as
- Code names: GA-101, R-7159, RO-5072759
- Generic name: afutuzumab
- Brand name: Gazyva, Gazyvaro