Difference between revisions of "Acalabrutinib (Calquence)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Irreversible inhibitor of [ | + | Class/mechanism: Irreversible inhibitor of [https://en.wikipedia.org/wiki/Bruton%27s_tyrosine_kinase Bruton's tyrosine kinase (BTK)], which is an enzyme that participates in the B-cell receptor (BCR) signal cascade and cytokine receptor pathways. BCR signaling is believed to promote cell proliferation, adhesion, and survival in B-cell malignancies. Inhibition of BTK interferes with the processes above, as well as B-cell chemotaxis and trafficking. More specific to BTK than the first-generation drug ibrutinib.<ref name="insert">[https://www.azpicentral.com/calquence/calquence.pdf Acalabrutinib (Calquence) package insert]</ref><ref>[[:File:Acalabrutinib.pdf | Acalabrutinib (Calquence) package insert (locally hosted backup)]]</ref><ref>[https://www.calquence.com/ Calquence manufacturer's website]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
| − | 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], [ | + | 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], [https://online.lexi.com/lco/action/login UpToDate Lexidrug], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> |
| − | ==Diseases for which it is established | + | ==Diseases for which it is established== |
*[[Chronic lymphocytic leukemia]] | *[[Chronic lymphocytic leukemia]] | ||
*[[Mantle cell lymphoma]] | *[[Mantle cell lymphoma]] | ||
| Line 12: | Line 12: | ||
==Patient drug information== | ==Patient drug information== | ||
*[https://www.azpicentral.com/calquence/calquence.pdf Acalabrutinib (Calquence) package insert]<ref name="insert"></ref> | *[https://www.azpicentral.com/calquence/calquence.pdf Acalabrutinib (Calquence) package insert]<ref name="insert"></ref> | ||
| − | *[https://chemocare.com/ | + | *[https://chemocare.com/druginfo/acalabrutinib.aspx Acalabrutinib (Calquence) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/acalabrutinib.aspx Acalabrutinib (Calquence) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/acalabrutinib-patient-drug-information Acalabrutinib (Calquence) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/acalabrutinib-patient-drug-information Acalabrutinib (Calquence) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/acalabrutinib-patient-drug-information Acalabrutinib (Calquence) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/acalabrutinib-patient-drug-information Acalabrutinib (Calquence) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *10 | + | *2017-10-31: Granted accelerated approval for treatment of adult patients with [[mantle cell lymphoma|mantle cell lymphoma (MCL)]] who have received at least one prior therapy. ''(Based on ACE-LY-004)'' |
| − | *11 | + | *2019-11-21: Approved for adults with [[Chronic lymphocytic leukemia|chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)]]. ''(Based on ELEVATE TN and ASCEND)'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | *11 | + | *2020-11-05: Initial authorization as Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated [[Chronic lymphocytic leukemia|chronic lymphocytic leukaemia (CLL)]]. |
| + | *2020-11-05: Initial authorization as Calquence as monotherapy is indicated for the treatment of adult patients with [[Chronic lymphocytic leukemia|chronic lymphocytic leukaemia (CLL)]] who have received at least one prior therapy. | ||
| + | |||
| + | ==History of changes in Health Canada indication== | ||
| + | *2019-08-23: Initial notice of compliance | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2021-01-22: Newly indicated for the treatment of relapsed or refractory [[Chronic lymphocytic leukemia|chronic lymphocytic leukemia/small lymphocytic lymphoma]]. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' ACP-196 | *'''Code name:''' ACP-196 | ||
| Line 38: | Line 44: | ||
[[Category:FDA approved in 2017]] | [[Category:FDA approved in 2017]] | ||
[[Category:EMA approved in 2020]] | [[Category:EMA approved in 2020]] | ||
| + | [[Category:Health Canada approved in 2019]] | ||
| + | [[Category:PMDA approved in 2021]] | ||
Revision as of 01:28, 27 June 2024
General information
Class/mechanism: Irreversible inhibitor of Bruton's tyrosine kinase (BTK), which is an enzyme that participates in the B-cell receptor (BCR) signal cascade and cytokine receptor pathways. BCR signaling is believed to promote cell proliferation, adhesion, and survival in B-cell malignancies. Inhibition of BTK interferes with the processes above, as well as B-cell chemotaxis and trafficking. More specific to BTK than the first-generation drug ibrutinib.[1][2][3]
Route: PO
Extravasation: n/a
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, UpToDate Lexidrug, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is established
Patient drug information
- Acalabrutinib (Calquence) package insert[1]
- Acalabrutinib (Calquence) patient drug information (Chemocare)[4]
- Acalabrutinib (Calquence) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2017-10-31: Granted accelerated approval for treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. (Based on ACE-LY-004)
- 2019-11-21: Approved for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (Based on ELEVATE TN and ASCEND)
History of changes in EMA indication
- 2020-11-05: Initial authorization as Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
- 2020-11-05: Initial authorization as Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
History of changes in Health Canada indication
- 2019-08-23: Initial notice of compliance
History of changes in PMDA indication
- 2021-01-22: Newly indicated for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.
Also known as
- Code name: ACP-196
- Brand name: Calquence