Difference between revisions of "Pertuzumab (Perjeta)"
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| − | ''' | + | '''FDA approved 6/8/2012.''' Also known as Omnitarg. |
==General information== | ==General information== | ||
| − | Class: Humanized monoclonal antibody that binds to subdomain II of HER2, preventing dimerization with other HER receptors, | + | Class: 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">[http://www.gene.com/gene/products/information/perjeta/pdf/perjeta_prescribing.pdf Pertuzumab (Perjeta) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/pertuzumab.pdf Pertuzumab (Perjeta) package insert (locally hosted backup)]</ref><ref>[http://www.perjeta.com/ Perjeta manufacturer's website]</ref> |
| − | + | ||
| + | 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. 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. | 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. | ||
| + | |||
| + | ==Clinical trials== | ||
| + | *[http://www.nejm.org/doi/full/10.1056/NEJMoa1113216 CLEOPATRA trial]<ref>Baselga J, Cortés J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, Clark E, Benyunes MC, Ross G, Swain SM; CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012 Jan 12;366(2):109-19. Epub 2011 Dec 7. [http://www.nejm.org/doi/full/10.1056/NEJMoa1113216 link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/22149875 PubMed]</ref> | ||
| + | *[http://www.sciencedirect.com/science/article/pii/S1470204511703369 NeoSphere trial]<ref>Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi G, Szado T, Ratnayake J, Ross G, Valagussa P. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012 Jan;13(1):25-32. Epub 2011 Dec 6. [http://www.sciencedirect.com/science/article/pii/S1470204511703369 link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/22153890 PubMed]</ref> | ||
==Patient drug information== | ==Patient drug information== | ||
| − | + | *[http://www.perjeta.com/patient/index Pertuzumab (Perjeta) patient drug information]<ref>[http://www.perjeta.com/patient/index Pertuzumab (Perjeta) patient drug information]</ref> | |
==References== | ==References== | ||
<references/> | <references/> | ||
Revision as of 15:47, 11 June 2012
FDA approved 6/8/2012. Also known as Omnitarg.
General information
Class: 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.
Clinical trials
Patient drug information
References
- ↑ Pertuzumab (Perjeta) package insert
- ↑ Pertuzumab (Perjeta) package insert (locally hosted backup)
- ↑ Perjeta manufacturer's website
- ↑ Baselga J, Cortés J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, Clark E, Benyunes MC, Ross G, Swain SM; CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012 Jan 12;366(2):109-19. Epub 2011 Dec 7. link to original article PubMed
- ↑ Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi G, Szado T, Ratnayake J, Ross G, Valagussa P. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012 Jan;13(1):25-32. Epub 2011 Dec 6. link to original article PubMed
- ↑ Pertuzumab (Perjeta) patient drug information