Difference between revisions of "Pertuzumab (Perjeta)"
Jump to navigation
Jump to search
m (Text replacement - "[[File:" to "[[:File:") |
m |
||
| Line 19: | Line 19: | ||
*9/30/2013: 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)'' | *9/30/2013: 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)'' | ||
*12/20/2017: [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) | *12/20/2017: [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) | ||
| + | |||
| + | ==History of changes in EMA indication== | ||
| + | *3/4/2013: Initial marketing authorization as Perjeta. | ||
==Also known as== | ==Also known as== | ||
| Line 30: | Line 33: | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
[[Category:Protein expression-specific medications]] | [[Category:Protein expression-specific medications]] | ||
| − | |||
[[Category:Anti-HER2 antibodies]] | [[Category:Anti-HER2 antibodies]] | ||
| Line 36: | Line 38: | ||
[[Category:Breast cancer medications]] | [[Category:Breast cancer medications]] | ||
[[Category:ERBB2 (HER2) medications]] | [[Category:ERBB2 (HER2) medications]] | ||
| + | |||
| + | [[Category:EMA approved in 2013]] | ||
[[Category:FDA approved in 2012]] | [[Category:FDA approved in 2012]] | ||
Revision as of 01:46, 5 December 2021
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 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
- 6/8/2012: 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)
- 9/30/2013: 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)
- 12/20/2017: 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
- 3/4/2013: Initial marketing authorization as Perjeta.
Also known as
- Code names: 2C4, Rhumab 2C4.
- Brand names: Omnitarg, Perjeta