Difference between revisions of "Pertuzumab (Perjeta)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Humanized monoclonal antibody that binds to the extracellular dimerization subdomain II of HER2, preventing dimerization with other HER receptors (i.e. EGFR/HER1, HER3, and HER4). Pertuzumab inhibits ligand-initiated intracellular signaling via the MAP (mitogen-activated protein) kinase and PI3K (phosphoinositide 3-kinase) pathways, which results in cell growth arrest and apoptosis. Also stimulates antibody-dependent cell-mediated cytotoxicity (ADCC).<ref name="insert">[ | + | Class/mechanism: Humanized monoclonal antibody that binds to the extracellular dimerization subdomain II of HER2, preventing dimerization with other HER receptors (i.e. EGFR/HER1, HER3, and HER4). Pertuzumab inhibits ligand-initiated intracellular signaling via the MAP (mitogen-activated protein) kinase and PI3K (phosphoinositide 3-kinase) pathways, which results in cell growth arrest and apoptosis. Also stimulates antibody-dependent cell-mediated cytotoxicity (ADCC).<ref name="insert">[https://www.gene.com/download/pdf/perjeta_prescribing.pdf Pertuzumab (Perjeta) package insert]</ref><ref>[[:File:Pertuzumab.pdf | Pertuzumab (Perjeta) package insert (locally hosted backup)]]</ref><ref>[http://www.perjeta.com/ Perjeta manufacturer's website]</ref> |
| − | + | <br>Route: IV | |
| − | 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. | + | 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== | ||
| + | *[[Breast_cancer,_HER2-positive|HER2+ breast cancer]] | ||
| + | *[[Colorectal cancer, HER2-positive|HER2+ colon cancer]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | *[[ | + | *[[Malignant solid neoplasm, ERBB2-mutated|HER2+ tumors (site-agnostic)]] |
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==Patient drug information== | ==Patient drug information== | ||
| − | *[ | + | *[https://www.gene.com/download/pdf/perjeta_prescribing.pdf Pertuzumab (Perjeta) package insert]<ref name="insert"></ref> |
| − | + | *[https://chemocare.com/druginfo/Pertuzumab.aspx Pertuzumab (Perjeta) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/Pertuzumab.aspx Pertuzumab (Perjeta) patient drug information (Chemocare)]</ref> | |
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*[http://www.uptodate.com/contents/pertuzumab-patient-drug-information Pertuzumab (Perjeta) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/pertuzumab-patient-drug-information Pertuzumab (Perjeta) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/pertuzumab-patient-drug-information Pertuzumab (Perjeta) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/pertuzumab-patient-drug-information Pertuzumab (Perjeta) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2012-06-08: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm307592.htm FDA approved] for use in combination with [[Trastuzumab (Herceptin)|trastuzumab]] and [[Docetaxel (Taxotere)|docetaxel]] for the treatment of patients with [[Biomarkers#HER2|HER2]]-[[Biomarkers#Overexpression|positive]] metastatic [[breast cancer]] who have '''not received''' prior anti-HER2 therapy or chemotherapy for metastatic disease. ''(Based on CLEOPATRA)'' |
| + | *2013-09-30: Granted accelerated approval for use in combination with [[Trastuzumab (Herceptin)|trastuzumab]] and [[Docetaxel (Taxotere)|docetaxel]] for the neoadjuvant treatment of patients with [[Biomarkers#HER2|HER2]]-[[Biomarkers#Overexpression|positive]], locally advanced, inflammatory, or early stage [[breast cancer]] (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. ''(Approval extended to the neoadjuvant setting; based on NeoSphere, TRYPHAENA, BERENICE)'' | ||
| + | **2017-12-20: [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-pertuzumab-adjuvant-treatment-her2-positive-breast-cancer Regular FDA approval] for use in combination with [[Trastuzumab (Herceptin)|trastuzumab]] and chemotherapy as adjuvant treatment of patients with [[Biomarkers#HER2|HER2]]-[[Biomarkers#Overexpression|positive]] early [[breast cancer]] at high risk of recurrence. ''(Granted regular approval; Approval extended to the adjuvant setting; based on APHINITY)'' | ||
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| + | ==History of changes in EMA indication== | ||
| + | *2013-03-04: Initial marketing authorization as Perjeta. Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable [[breast cancer]], who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. ''(Based on CLEOPATRA)'' | ||
| + | *2015-07-28: Extension of indication to include the use of pertuzumab in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage [[breast cancer]] at high risk of recurrence. | ||
| + | *2018-05-31: Extension of indication for Perjeta, in combination with trastuzumab and chemotherapy, for the adjuvant treatment of adult patients with HER2-positive early [[breast cancer]] at high risk of recurrence. ''(Based on APHINITY)'' | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2012-08-31: Initial notice of compliance for the treatment of patients with HER2-positive metastatic [[breast cancer]] who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2013-06-28: Initial approval for the treatment of unresectable or recurrent HER2-positive [[breast cancer]]. | ||
| + | *2018-10-10: New indication for the treatment of HER2-positive [[breast cancer]]. | ||
| + | *2022-03-28: New indication and a new dosage for the treatment of unresectable advanced or recurrent HER2-positive [[Colorectal cancer|colon or rectal cancer]] that has progressed after cancer chemotherapy. | ||
==Also known as== | ==Also known as== | ||
| − | 2C4 | + | *'''Code names:''' 2C4, Rhumab 2C4. |
| + | *'''Brand names:''' Omnitarg, Perjeta | ||
==References== | ==References== | ||
<references/> | <references/> | ||
| − | [[Category: | + | [[Category:Drugs]] |
| − | [[Category: | + | [[Category:Intravenous medications]] |
| − | [[Category: | + | [[Category:Protein expression-specific medications]] |
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| + | [[Category:Anti-HER2 antibodies]] | ||
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[[Category:Breast cancer medications]] | [[Category:Breast cancer medications]] | ||
| − | [[Category: | + | [[Category:Colorectal cancer medications]] |
| + | [[Category:Malignant solid neoplasm, ERBB2-mutated medications]] | ||
| + | |||
| + | [[Category:EMA approved in 2013]] | ||
| + | [[Category:FDA approved in 2012]] | ||
| + | [[Category:Health Canada approved in 2012]] | ||
| + | [[Category:PMDA approved in 2013]] | ||
Latest revision as of 21:15, 21 September 2023
General information
Class/mechanism: Humanized monoclonal antibody that binds to the extracellular dimerization subdomain II of HER2, preventing dimerization with other HER receptors (i.e. EGFR/HER1, HER3, and HER4). Pertuzumab inhibits ligand-initiated intracellular signaling via the MAP (mitogen-activated protein) kinase and PI3K (phosphoinositide 3-kinase) pathways, which results in cell growth arrest and apoptosis. Also stimulates antibody-dependent cell-mediated cytotoxicity (ADCC).[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
Diseases for which it is used
Patient drug information
- Pertuzumab (Perjeta) package insert[1]
- Pertuzumab (Perjeta) patient drug information (Chemocare)[4]
- Pertuzumab (Perjeta) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2012-06-08: FDA approved for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. (Based on CLEOPATRA)
- 2013-09-30: Granted accelerated approval for use in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. (Approval extended to the neoadjuvant setting; based on NeoSphere, TRYPHAENA, BERENICE)
- 2017-12-20: Regular FDA approval for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. (Granted regular approval; Approval extended to the adjuvant setting; based on APHINITY)
History of changes in EMA indication
- 2013-03-04: Initial marketing authorization as Perjeta. Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. (Based on CLEOPATRA)
- 2015-07-28: Extension of indication to include the use of pertuzumab in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
- 2018-05-31: Extension of indication for Perjeta, in combination with trastuzumab and chemotherapy, for the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. (Based on APHINITY)
History of changes in Health Canada indication
- 2012-08-31: Initial notice of compliance for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
History of changes in PMDA indication
- 2013-06-28: Initial approval for the treatment of unresectable or recurrent HER2-positive breast cancer.
- 2018-10-10: New indication for the treatment of HER2-positive breast cancer.
- 2022-03-28: New indication and a new dosage for the treatment of unresectable advanced or recurrent HER2-positive colon or rectal cancer that has progressed after cancer chemotherapy.
Also known as
- Code names: 2C4, Rhumab 2C4.
- Brand names: Omnitarg, Perjeta