Difference between revisions of "Panitumumab (Vectibix)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * 9/27/2006: Accelerated FDA approval "for the treatment of EGFR-expressing, metastatic [[Colon cancer|colorectal carcinoma]] with disease progression on or following [[Fluorouracil (5-FU)|fluoropyrimidine-]], [[Oxaliplatin (Eloxatin)|oxaliplatin-]], and [[Irinotecan (Camptosar)|irinotecan-]] containing chemotherapy regimens." | + | * 9/27/2006: Accelerated FDA approval "for the treatment of [[Biomarkers#EGFR|EGFR]]-expressing, metastatic [[Colon cancer|colorectal carcinoma]] with disease progression on or following [[Fluorouracil (5-FU)|fluoropyrimidine-]], [[Oxaliplatin (Eloxatin)|oxaliplatin-]], and [[Irinotecan (Camptosar)|irinotecan-]] containing chemotherapy regimens." |
| − | * 8/17/2012: Restriction placed: "'''not indicated''' for the treatment of patients with KRAS mutation-positive mCRC or for whom KRAS mCRC status is unknown." | + | * 8/17/2012: Restriction placed: "'''not indicated''' for the treatment of patients with [[Biomarkers#KRAS|KRAS]] [[Biomarkers#mutation|mutation]]-positive mCRC or for whom [[Biomarkers#KRAS|KRAS]] mCRC status is unknown." |
| − | * 5/23/2014: Label revised "for the treatment of wild-type KRAS (exon 2) metastatic [[Colon cancer|colorectal cancer (mCRC)]] as determined by an FDA-approved test for this use: | + | * 5/23/2014: Label revised "for the treatment of [[Biomarkers#wild-type|wild-type]] [[Biomarkers#KRAS|KRAS]] ([[Biomarkers#exon|exon]] 2) metastatic [[Colon cancer|colorectal cancer (mCRC)]] as determined by an FDA-approved test for this use: |
# In combination with [[Colon_cancer#FOLFOX_.26_Panitumumab|FOLFOX]] for first-line treatment. | # In combination with [[Colon_cancer#FOLFOX_.26_Panitumumab|FOLFOX]] for first-line treatment. | ||
# As monotherapy following disease progression after prior treatment with [[Fluorouracil (5-FU)|fluoropyrimidine]], [[Oxaliplatin (Eloxatin)|oxaliplatin]], and [[Irinotecan (Camptosar)|irinotecan-]] containing chemotherapy." | # As monotherapy following disease progression after prior treatment with [[Fluorouracil (5-FU)|fluoropyrimidine]], [[Oxaliplatin (Eloxatin)|oxaliplatin]], and [[Irinotecan (Camptosar)|irinotecan-]] containing chemotherapy." | ||
Revision as of 00:03, 9 January 2020
General information
Class/mechanism: EGFR antagonist; recombinant human IgG2 kappa monoclonal antibody that binds to EGFR (human epidermal growth factor receptor), competitively inhibiting binding of epidermal growth factor (EGF). EGFR is overexpressed in certain cancers, such as colon & rectal cancer, and plays a role in the signal transduction pathways that lead to transcription of genes that promote cell growth, survival, and motility. Blocking EGFR in a population overexpressing EGFR has been observed to inhibit cell growth and induce apoptosis.[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 prescribing information.[1]
Diseases for which it is used
Patient drug information
- Panitumumab (Vectibix) patient drug information (Chemocare)[4]
- Brief patient counseling information can be found on page 15 of the Panitumumab (Vectibix) package insert[1]
- Panitumumab (Vectibix) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 9/27/2006: Accelerated FDA approval "for the treatment of EGFR-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens."
- 8/17/2012: Restriction placed: "not indicated for the treatment of patients with KRAS mutation-positive mCRC or for whom KRAS mCRC status is unknown."
- 5/23/2014: Label revised "for the treatment of wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) as determined by an FDA-approved test for this use:
- In combination with FOLFOX for first-line treatment.
- As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan- containing chemotherapy."
Also known as
- Generic names: ABX-EGF, clone E7.6.3
- Brand name: Vectibix