Difference between revisions of "Palbociclib (Ibrance)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Cyclin-dependent kinase 4 and 6 inhibitor. Cyclin D1, CDK4, and CDK6 are downstream of signaling pathways which result in cellular proliferation. The use of palbociclib with antiestrogens was observed to increase growth arrest in estrogen receptor (ER)-positive breast cancer cell lines by decreasing retinoblastoma protein (Rb) phosphorylation, which resulted in reduced E2F expression and signaling. Palbociclib has been observed to cause cell cycle arrest between G1 to S phase of the cell cycle in ER-positive breast cancer cell lines.<ref name=insert>[http://labeling.pfizer.com/ShowLabeling.aspx?id=2191 Palbociclib (Ibrance) package insert]</ref><ref>[[ | + | Class/mechanism: Cyclin-dependent kinase 4 and 6 inhibitor. Cyclin D1, CDK4, and CDK6 are downstream of signaling pathways which result in cellular proliferation. The use of palbociclib with antiestrogens was observed to increase growth arrest in estrogen receptor (ER)-positive breast cancer cell lines by decreasing retinoblastoma protein (Rb) phosphorylation, which resulted in reduced E2F expression and signaling. Palbociclib has been observed to cause cell cycle arrest between G1 to S phase of the cell cycle in ER-positive breast cancer cell lines.<ref name=insert>[http://labeling.pfizer.com/ShowLabeling.aspx?id=2191 Palbociclib (Ibrance) package insert]</ref><ref>[[:File:Palbociclib.pdf|Palbociclib (Ibrance) package insert (locally hosted backup)]]</ref><ref>[http://www.ibrance.com/ Ibrance manufacturer's website]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
| Line 11: | Line 11: | ||
==Patient drug information== | ==Patient drug information== | ||
*[http://labeling.pfizer.com/ShowLabeling.aspx?id=2191 Palbociclib (Ibrance) package insert]<ref name="insert"></ref> | *[http://labeling.pfizer.com/ShowLabeling.aspx?id=2191 Palbociclib (Ibrance) package insert]<ref name="insert"></ref> | ||
| − | *[ | + | *[https://chemocare.com/druginfo/palbociclib.aspx Palbociclib (Ibrance) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/palbociclib.aspx Palbociclib (Ibrance) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/palbociclib-patient-drug-information Palbociclib (Ibrance) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/palbociclib-patient-drug-information Palbociclib (Ibrance) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/palbociclib-patient-drug-information Palbociclib (Ibrance) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/palbociclib-patient-drug-information Palbociclib (Ibrance) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2015-02-03: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm432886.htm Accelerated FDA approval] to be used in combination with [[Letrozole (Femara) | letrozole]] for the treatment of postmenopausal women with [[Biomarkers#ER|estrogen receptor (ER)]]-[[Biomarkers#Expression|positive]], [[Biomarkers#HER2|human epidermal growth factor receptor 2 (HER2)]]-[[Biomarkers#Normal_expression|negative]] advanced [[Breast_cancer|breast cancer]] as initial endocrine-based therapy for their metastatic disease. ''(Based on PALOMA-2)'' |
| − | * | + | *2016-02-19: FDA approval expanded in combination with [[Fulvestrant (Faslodex)|fulvestrant]] for the treatment of women with [[Biomarkers#HR|hormone receptor (HR)]]-[[Biomarkers#Expression|positive]], [[Biomarkers#HER2|human epidermal growth factor receptor 2 (HER2)]]-[[Biomarkers#Normal_expression|negative]] advanced or metastatic [[breast cancer]] with disease progression following endocrine therapy. ''(Based on PALOMA-3)'' |
| − | * | + | *2017-03-31: Granted regular approval for the treatment of [[Biomarkers#HR|hormone receptor (HR)]] [[Biomarkers#Expression|positive]], [[Biomarkers#HER2|human epidermal growth factor receptor 2 (HER2)]] [[Biomarkers#Normal_expression|negative]] advanced or metastatic [[breast cancer]] in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women. ''(Based on PALOMA-2)'' |
| + | ==History of changes in EMA indication== | ||
| + | *2016-11-09: Initial authorization | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2016-03-16: Initial notice of compliance with conditions | ||
| + | *2016-11-17: Conditions were met | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2017-09-27: New approval for the treatment of unresectable or recurrent [[breast cancer]]. | ||
| + | *2020-01-23: New indication in a new dosage form for the treatment of hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative inoperable or recurrent [[breast cancer]]. | ||
==Also known as== | ==Also known as== | ||
| Line 35: | Line 43: | ||
[[Category:Breast cancer medications]] | [[Category:Breast cancer medications]] | ||
[[Category:FDA approved in 2015]] | [[Category:FDA approved in 2015]] | ||
| + | [[Category:EMA approved in 2016]] | ||
| + | [[Category:Health Canada approved in 2016]] | ||
| + | [[Category:PMDA approved in 2017]] | ||
Revision as of 23:29, 2 September 2023
General information
Class/mechanism: Cyclin-dependent kinase 4 and 6 inhibitor. Cyclin D1, CDK4, and CDK6 are downstream of signaling pathways which result in cellular proliferation. The use of palbociclib with antiestrogens was observed to increase growth arrest in estrogen receptor (ER)-positive breast cancer cell lines by decreasing retinoblastoma protein (Rb) phosphorylation, which resulted in reduced E2F expression and signaling. Palbociclib has been observed to cause cell cycle arrest between G1 to S phase of the cell cycle in ER-positive breast cancer cell lines.[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, Lexicomp, UpToDate (courtesy of Lexicomp), or the package insert.[1]
Diseases for which it is used
Patient drug information
- Palbociclib (Ibrance) package insert[1]
- Palbociclib (Ibrance) patient drug information (Chemocare)[4]
- Palbociclib (Ibrance) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2015-02-03: Accelerated FDA approval to be used in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. (Based on PALOMA-2)
- 2016-02-19: FDA approval expanded in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (Based on PALOMA-3)
- 2017-03-31: Granted regular approval for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women. (Based on PALOMA-2)
History of changes in EMA indication
- 2016-11-09: Initial authorization
History of changes in Health Canada indication
- 2016-03-16: Initial notice of compliance with conditions
- 2016-11-17: Conditions were met
History of changes in PMDA indication
- 2017-09-27: New approval for the treatment of unresectable or recurrent breast cancer.
- 2020-01-23: New indication in a new dosage form for the treatment of hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative inoperable or recurrent breast cancer.
Also known as
- Code name: PD-0332991
- Brand names: Ibrance, Lucipalb, Palbace, Palbocap, Palbocent, Palbonix