Difference between revisions of "Pertuzumab (Perjeta)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *6/8/2012: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm307592.htm FDA approved] | + | *6/8/2012: [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 [[Breast_cancer,_HER2-positive|HER2-positive metastatic breast cancer]] who have '''not received''' prior anti-HER2 therapy or chemotherapy for metastatic disease. |
| − | *12/20/2017: Granted regular FDA approval for use in combination with [[Trastuzumab (Herceptin)|trastuzumab]] and chemotherapy as adjuvant treatment of patients with [[Breast_cancer,_HER2-positive|HER2-positive early breast cancer]] at high risk of recurrence. | + | *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 [[Breast_cancer,_HER2-positive|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) |
| + | *12/20/2017: Granted regular FDA approval for use in combination with [[Trastuzumab (Herceptin)|trastuzumab]] and chemotherapy as adjuvant treatment of patients with [[Breast_cancer,_HER2-positive|HER2-positive early breast cancer]] at high risk of recurrence. ''(Granted regular approval; Approval extended to the adjuvant setting) | ||
==Also known as== | ==Also known as== | ||
Revision as of 22:40, 29 November 2018
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) patient drug information (Chemocare)[4]
- Pertuzumab (Perjeta) patient drug information[5]
- Brief patient counseling information can be found on page 16 of the package insert[1]
- Pertuzumab (Perjeta) patient drug information (UpToDate)[6]
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.
- 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)
- 12/20/2017: Granted 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)
Also known as
- Code names: 2C4, Rhumab 2C4.
- Brand names: Omnitarg, Perjeta
References
- ↑ 1.0 1.1 1.2 Pertuzumab (Perjeta) package insert
- ↑ Pertuzumab (Perjeta) package insert (locally hosted backup)
- ↑ Perjeta manufacturer's website
- ↑ Pertuzumab (Perjeta) patient drug information (Chemocare)
- ↑ Pertuzumab (Perjeta) patient drug information
- ↑ Pertuzumab (Perjeta) patient drug information (UpToDate)