Difference between revisions of "Ibrutinib (Imbruvica)"
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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.<ref name=insert>[https://www.imbruvica.com/files/prescribing-information.pdf Ibrutinib (Imbruvica) package insert]</ref><ref>[[:File:Ibrutinib.pdf | Ibrutinib (Imbruvica) package insert (locally hosted backup)]]</ref><ref>[http://www.imbruvica.com/ Imbruvica manufacturer's website]</ref> |
<ref>[http://www.pharmacyclics.com/productpipeline1.html Pharmacyclics BTK inhibitor website]</ref> | <ref>[http://www.pharmacyclics.com/productpipeline1.html Pharmacyclics BTK inhibitor 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 | + | 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 or the prescribing information.<ref name="insert"></ref> |
==Resistance mechanisms== | ==Resistance mechanisms== | ||
| − | # Woyach JA, Furman RR, Liu TM, Ozer HG, Zapatka M, Ruppert AS, Xue L, Li DH, Steggerda SM, Versele M, Dave SS, Zhang J, Yilmaz AS, Jaglowski SM, Blum KA, Lozanski A, Lozanski G, James DF, Barrientos JC, Lichter P, Stilgenbauer S, Buggy JJ, Chang BY, Johnson AJ, Byrd JC. Resistance mechanisms for the Bruton's tyrosine kinase inhibitor ibrutinib. N Engl J Med. 2014 Jun 12;370(24):2286-94. Epub 2014 May 28. [https:// | + | # Woyach JA, Furman RR, Liu TM, Ozer HG, Zapatka M, Ruppert AS, Xue L, Li DH, Steggerda SM, Versele M, Dave SS, Zhang J, Yilmaz AS, Jaglowski SM, Blum KA, Lozanski A, Lozanski G, James DF, Barrientos JC, Lichter P, Stilgenbauer S, Buggy JJ, Chang BY, Johnson AJ, Byrd JC. Resistance mechanisms for the Bruton's tyrosine kinase inhibitor ibrutinib. N Engl J Med. 2014 Jun 12;370(24):2286-94. Epub 2014 May 28. [https://doi.org/10.1056/NEJMoa1400029 link to original article] [https://pubmed.ncbi.nlm.nih.gov/24869598/ PubMed] |
==Significant side effects== | ==Significant side effects== | ||
| − | # '''Review:''' Leong DP, Caron F, Hillis C, Duan A, Healey JS, Fraser G, Siegal D. The risk of atrial fibrillation with ibrutinib use: a systematic review and meta-analysis. Blood. 2016 Jul 7;128(1):138-40. Epub 2016 May 31. [ | + | ===Cardiovascular=== |
| − | # '''Review:''' Caron F, Leong DP, Hillis C, Fraser G, Siegal D. Current understanding of bleeding with ibrutinib use: a systematic review and meta-analysis. Blood Adv. 2017 May 9;1(12):772-778. eCollection 2017 May 9. Review. [http://www.bloodadvances.org/content/1/12/772 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5728050/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29296721 PubMed] | + | # '''Review:''' Leong DP, Caron F, Hillis C, Duan A, Healey JS, Fraser G, Siegal D. The risk of atrial fibrillation with ibrutinib use: a systematic review and meta-analysis. Blood. 2016 Jul 7;128(1):138-40. Epub 2016 May 31. [https://doi.org/10.1182/blood-2016-05-712828 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27247135/ PubMed] |
| − | # '''Review:''' Tillman BF, Pauff JM, Satyanarayana G, Talbott M, Warner JL. Systematic review of infectious events with the Bruton tyrosine kinase inhibitor ibrutinib in the treatment of hematologic malignancies. Eur J Haematol. 2018 Apr;100(4):325-334. Epub 2018 Feb 6. [https:// | + | # Dickerson T, Wiczer T, Waller A, Philippon J, Porter K, Haddad D, Guha A, Rogers KA, Bhat S, Byrd JC, Woyach JA, Awan F, Addison D. Hypertension and incident cardiovascular events following ibrutinib initiation. Blood. 2019 Nov 28;134(22):1919-1928. [https://doi.org/10.1182/blood.2019000840 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31582362/ PubMed] |
| − | # Ghez D, Calleja A, Protin C, Baron M, Ledoux MP, Damaj G, Dupont M, Dreyfus B, Ferrant E, Herbaux C, Laribi K, Le Calloch R, Malphettes M, Paul F, Souchet L, Truchan-Graczyk M, Delavigne K, Dartigeas C, Ysebaert L; on behalf on the French Innovative Leukemia Organization (FILO) CLL group. Early-onset invasive aspergillosis and other fungal infections in patients treated with ibrutinib. Blood. 2018 Apr 26;131(17):1955-1959. Epub 2018 Feb 1. [ | + | |
| − | + | ===Hematologic=== | |
| + | # '''Review:''' Caron F, Leong DP, Hillis C, Fraser G, Siegal D. Current understanding of bleeding with ibrutinib use: a systematic review and meta-analysis. Blood Adv. 2017 May 9;1(12):772-778. eCollection 2017 May 9. Review. [http://www.bloodadvances.org/content/1/12/772 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5728050/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29296721/ PubMed] | ||
| + | |||
| + | ===Infectious=== | ||
| + | # '''Review:''' Tillman BF, Pauff JM, Satyanarayana G, Talbott M, Warner JL. Systematic review of infectious events with the Bruton tyrosine kinase inhibitor ibrutinib in the treatment of hematologic malignancies. Eur J Haematol. 2018 Apr;100(4):325-334. Epub 2018 Feb 6. [https://doi.org/10.1111/ejh.13020 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29285806/ PubMed] | ||
| + | # Ghez D, Calleja A, Protin C, Baron M, Ledoux MP, Damaj G, Dupont M, Dreyfus B, Ferrant E, Herbaux C, Laribi K, Le Calloch R, Malphettes M, Paul F, Souchet L, Truchan-Graczyk M, Delavigne K, Dartigeas C, Ysebaert L; on behalf on the French Innovative Leukemia Organization (FILO) CLL group. Early-onset invasive aspergillosis and other fungal infections in patients treated with ibrutinib. Blood. 2018 Apr 26;131(17):1955-1959. Epub 2018 Feb 1. [https://doi.org/10.1182/blood-2017-11-818286 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29437588/ PubMed] | ||
| + | |||
| + | ==Diseases for which it is established ''(work in progress)''== | ||
| + | *[[Chronic lymphocytic leukemia]] | ||
| + | *[[Graft versus host disease]] | ||
| + | *[[Waldenström macroglobulinemia]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | |||
*[[Diffuse large B-cell lymphoma]] | *[[Diffuse large B-cell lymphoma]] | ||
*[[Follicular lymphoma]] | *[[Follicular lymphoma]] | ||
| − | |||
*[[Mantle cell lymphoma]] | *[[Mantle cell lymphoma]] | ||
*[[Marginal zone lymphoma]] | *[[Marginal zone lymphoma]] | ||
*[[T-cell prolymphocytic leukemia]] | *[[T-cell prolymphocytic leukemia]] | ||
| − | |||
==Patient drug information== | ==Patient drug information== | ||
| − | *[https://www.imbruvica.com/ | + | *[https://www.imbruvica.com/files/prescribing-information.pdf Ibrutinib (Imbruvica) package insert]<ref name="insert"></ref> |
| − | *[ | + | *[https://chemocare.com/druginfo/ibrutinib.aspx Ibrutinib (Imbruvica) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/ibrutinib.aspx Ibrutinib (Imbruvica) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/ibrutinib-patient-drug-information Ibrutinib (Imbruvica) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/ibrutinib-patient-drug-information Ibrutinib (Imbruvica) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/ibrutinib-patient-drug-information Ibrutinib (Imbruvica) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/ibrutinib-patient-drug-information Ibrutinib (Imbruvica) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
===[[Graft versus host disease|Chronic graft versus host disease (cGVHD)]]=== | ===[[Graft versus host disease|Chronic graft versus host disease (cGVHD)]]=== | ||
| − | * | + | *2017-08-02: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm569711.htm FDA indication expanded] for the treatment of adult patients with [[Graft versus host disease|chronic graft versus host disease (cGVHD)]] after failure of one or more lines of systemic therapy. ''(Based on PCYC-1129-CA)'' |
| − | + | *2022-08-24: Approved for pediatric patients at least 1 year of age with [[Graft versus host disease|chronic graft versus host disease (cGVHD)]] after failure of 1 or more lines of systemic therapy. ''(Based on iMAGINE)'' | |
===[[Chronic lymphocytic leukemia]]=== | ===[[Chronic lymphocytic leukemia]]=== | ||
| − | * | + | *2014-02-12: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm385878.htm Granted accelerated approval] for the treatment of patients with [[Chronic lymphocytic leukemia | chronic lymphocytic leukemia (CLL)]] who have received at least one prior therapy. ''(Based on PCYC-1102 relapsed, RESONATE, HELIOS)'' |
| − | * | + | **2014-07-28: Converted to regular approval and approval expanded to include patients with [[Chronic lymphocytic leukemia | chronic lymphocytic leukemia (CLL)]] who carry a deletion in chromosome 17 ([[Biomarkers#17p|17p]] [[Biomarkers#Deletion|deletion]]). ''(Based on RESONATE and iLLUMINATE)'' |
| − | * | + | *2016-03-04: Approval expanded for the treatment of patients with [[Chronic lymphocytic leukemia |chronic lymphocytic leukemia (CLL)]]. ''(Based on RESONATE-2 and HELIOS)'' |
| − | * | + | *2020-04-21: Approval expanded to include its combination with rituximab for the initial treatment of adult patients with [[Chronic lymphocytic leukemia |chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)]]. ''(Based on ECOG E1912)'' |
| − | ===[[Mantle cell lymphoma]]=== | + | ===[[Mantle cell lymphoma]] - '''WITHDRAWN'''=== |
| − | *11 | + | *2013-11-13: Accelerated approval for the treatment of patients with [[Mantle cell lymphoma | mantle cell lymphoma (MCL)]] who have received at least one prior therapy. ''(Based on PCYC-1104-CA)'' |
| + | **2023-05-18: Accelerated approval for the treatment of patients with [[Mantle cell lymphoma | mantle cell lymphoma (MCL)]] who have received at least one prior therapy withdrawn. | ||
| − | ===[[Marginal zone lymphoma]]=== | + | ===[[Marginal zone lymphoma]] - '''WITHDRAWN'''=== |
| − | * | + | *2017-01-18: Accelerated approval for treatment of patients with [[Marginal zone lymphoma|marginal zone lymphoma (MZL)]] who require systemic therapy and have received at least one prior [[Regimen_classes#Anti-CD20-based_regimen|anti-CD20-based therapy]]. ''(Based on PCYC-1121-CA)'' |
| + | **2023-05-18: Accelerated approval for treatment of patients with [[Marginal zone lymphoma|marginal zone lymphoma (MZL)]] who require systemic therapy and have received at least one prior [[Regimen_classes#Anti-CD20-based_regimen|anti-CD20-based therapy]] withdrawn. | ||
===[[Waldenström macroglobulinemia]]=== | ===[[Waldenström macroglobulinemia]]=== | ||
| − | * | + | *2015-01-29: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm432240.htm FDA approval expanded] for the treatment of patients with [[Waldenström macroglobulinemia|Waldenström’s macroglobulinemia (WM)]]. ''(Based on DFCI 12-015 and iNNOVATE)'' |
| + | |||
| + | ==History of changes in EMA indication== | ||
| + | *2014-10-21: Initial authorization | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2015-07-28: Initial notice of compliance with conditions | ||
| + | *2017-09-12: Conditions were met | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2016-03-26: Initial approval for the treatment of relapsed or refractory [[chronic lymphocytic leukemia|chronic lymphocytic leukemia/small lymphocytic lymphoma]]. | ||
| + | *2016-12-02: New additional indication and a new dosage for the treatment of relapsed or refractory [[mantle cell lymphoma]]. | ||
| + | *2018-07-02: New additional indication for the treatment of [[chronic lymphocytic leukemia|chronic lymphocytic leukemia (including small lymphocytic lymphoma)]]. | ||
| + | *2021-09-27: new indication and a new dosage for the treatment of chronic [[Graft versus host disease|graft-versus-host disease after hematopoietic stem cell transplantation]] (for use when steroid drugs are not sufficiently effective). | ||
==Also known as== | ==Also known as== | ||
| Line 78: | Line 98: | ||
[[Category:FDA approved in 2013]] | [[Category:FDA approved in 2013]] | ||
| − | [[Category:PMDA approved | + | [[Category:EMA approved in 2014]] |
| + | [[Category:Health Canada approved in 2015]] | ||
| + | [[Category:PMDA approved in 2016]] | ||
| + | [[Category:WHO Essential Cancer Medicine]] | ||
Latest revision as of 01:06, 29 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.[1][2][3]
[4]
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 or the prescribing information.[1]
Resistance mechanisms
- Woyach JA, Furman RR, Liu TM, Ozer HG, Zapatka M, Ruppert AS, Xue L, Li DH, Steggerda SM, Versele M, Dave SS, Zhang J, Yilmaz AS, Jaglowski SM, Blum KA, Lozanski A, Lozanski G, James DF, Barrientos JC, Lichter P, Stilgenbauer S, Buggy JJ, Chang BY, Johnson AJ, Byrd JC. Resistance mechanisms for the Bruton's tyrosine kinase inhibitor ibrutinib. N Engl J Med. 2014 Jun 12;370(24):2286-94. Epub 2014 May 28. link to original article PubMed
Significant side effects
Cardiovascular
- Review: Leong DP, Caron F, Hillis C, Duan A, Healey JS, Fraser G, Siegal D. The risk of atrial fibrillation with ibrutinib use: a systematic review and meta-analysis. Blood. 2016 Jul 7;128(1):138-40. Epub 2016 May 31. link to original article PubMed
- Dickerson T, Wiczer T, Waller A, Philippon J, Porter K, Haddad D, Guha A, Rogers KA, Bhat S, Byrd JC, Woyach JA, Awan F, Addison D. Hypertension and incident cardiovascular events following ibrutinib initiation. Blood. 2019 Nov 28;134(22):1919-1928. link to original article PubMed
Hematologic
- Review: Caron F, Leong DP, Hillis C, Fraser G, Siegal D. Current understanding of bleeding with ibrutinib use: a systematic review and meta-analysis. Blood Adv. 2017 May 9;1(12):772-778. eCollection 2017 May 9. Review. link to original article link to PMC article PubMed
Infectious
- Review: Tillman BF, Pauff JM, Satyanarayana G, Talbott M, Warner JL. Systematic review of infectious events with the Bruton tyrosine kinase inhibitor ibrutinib in the treatment of hematologic malignancies. Eur J Haematol. 2018 Apr;100(4):325-334. Epub 2018 Feb 6. link to original article PubMed
- Ghez D, Calleja A, Protin C, Baron M, Ledoux MP, Damaj G, Dupont M, Dreyfus B, Ferrant E, Herbaux C, Laribi K, Le Calloch R, Malphettes M, Paul F, Souchet L, Truchan-Graczyk M, Delavigne K, Dartigeas C, Ysebaert L; on behalf on the French Innovative Leukemia Organization (FILO) CLL group. Early-onset invasive aspergillosis and other fungal infections in patients treated with ibrutinib. Blood. 2018 Apr 26;131(17):1955-1959. Epub 2018 Feb 1. link to original article PubMed
Diseases for which it is established (work in progress)
Diseases for which it is used
- Diffuse large B-cell lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Marginal zone lymphoma
- T-cell prolymphocytic leukemia
Patient drug information
- Ibrutinib (Imbruvica) package insert[1]
- Ibrutinib (Imbruvica) patient drug information (Chemocare)[5]
- Ibrutinib (Imbruvica) patient drug information (UpToDate)[6]
History of changes in FDA indication
Chronic graft versus host disease (cGVHD)
- 2017-08-02: FDA indication expanded for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. (Based on PCYC-1129-CA)
- 2022-08-24: Approved for pediatric patients at least 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. (Based on iMAGINE)
Chronic lymphocytic leukemia
- 2014-02-12: Granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. (Based on PCYC-1102 relapsed, RESONATE, HELIOS)
- 2014-07-28: Converted to regular approval and approval expanded to include patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion). (Based on RESONATE and iLLUMINATE)
- 2016-03-04: Approval expanded for the treatment of patients with chronic lymphocytic leukemia (CLL). (Based on RESONATE-2 and HELIOS)
- 2020-04-21: Approval expanded to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (Based on ECOG E1912)
Mantle cell lymphoma - WITHDRAWN
- 2013-11-13: Accelerated approval for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. (Based on PCYC-1104-CA)
- 2023-05-18: Accelerated approval for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy withdrawn.
Marginal zone lymphoma - WITHDRAWN
- 2017-01-18: Accelerated approval for treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. (Based on PCYC-1121-CA)
- 2023-05-18: Accelerated approval for treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy withdrawn.
Waldenström macroglobulinemia
- 2015-01-29: FDA approval expanded for the treatment of patients with Waldenström’s macroglobulinemia (WM). (Based on DFCI 12-015 and iNNOVATE)
History of changes in EMA indication
- 2014-10-21: Initial authorization
History of changes in Health Canada indication
- 2015-07-28: Initial notice of compliance with conditions
- 2017-09-12: Conditions were met
History of changes in PMDA indication
- 2016-03-26: Initial approval for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.
- 2016-12-02: New additional indication and a new dosage for the treatment of relapsed or refractory mantle cell lymphoma.
- 2018-07-02: New additional indication for the treatment of chronic lymphocytic leukemia (including small lymphocytic lymphoma).
- 2021-09-27: new indication and a new dosage for the treatment of chronic graft-versus-host disease after hematopoietic stem cell transplantation (for use when steroid drugs are not sufficiently effective).
Also known as
- Code names: CRA-032765, PCI-32765
- Brand names: Ibrunib, Ibrutix, Imbruvica, Lucibru
References
- ↑ 1.0 1.1 1.2 Ibrutinib (Imbruvica) package insert
- ↑ Ibrutinib (Imbruvica) package insert (locally hosted backup)
- ↑ Imbruvica manufacturer's website
- ↑ Pharmacyclics BTK inhibitor website
- ↑ Ibrutinib (Imbruvica) patient drug information (Chemocare)
- ↑ Ibrutinib (Imbruvica) patient drug information (UpToDate)
Categories:
- Drugs
- Mutation-specific medications
- Oral medications
- BTK inhibitors
- EGFR inhibitors
- ITK inhibitors
- TEC inhibitors
- TXK inhibitors
- Chronic lymphocytic leukemia medications
- Diffuse large B-cell lymphoma medications
- Follicular lymphoma medications
- Graft versus host disease medications
- Mantle cell lymphoma medications
- Marginal zone lymphoma medications
- T-cell prolymphocytic leukemia medications
- Waldenström macroglobulinemia medications
- FDA approved in 2013
- EMA approved in 2014
- Health Canada approved in 2015
- PMDA approved in 2016
- WHO Essential Cancer Medicine