Panitumumab

Therapeutic Panitumumab antibody from the original Vectibix® commercial drug.

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EGFR
Monoclonal Antibody
Vectibix®
20 mg/mL
2 mg
-80 °C
02/2025
230,00 
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Vectibix® / Panitumumab Reference Product

Drug nameVectibix®
INNPanitumumab
API typePanitumumab is a fully human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
Pharmacotherapeutic group
Antineoplastic agents, monoclonal antibodies and antibody drug-conjugates
ATC code
L01FE02
Target of antibody
EGFR
General functionVectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): (1) in first-line in combination with FOLFOX or FOLFIRI, (2) in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine based chemotherapy (excluding irinotecan), and (3) as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Panitumumab is a recombinant, fully human IgG2 monoclonal antibody that binds with high affinity and specificity to the human EGFR. EGFR is a transmembrane glycoprotein that is a member of a subfamily of type I receptor tyrosine kinases including EGFR (HER1/c-ErbB-1), HER2, HER3, and HER4. EGFR promotes cell growth in normal epithelial tissues, including the skin and hair follicle, and is expressed on a variety of tumour cells.
Panitumumab binds to the ligand binding domain of EGFR and inhibits receptor autophosphorylation induced by all known EGFR ligands. Binding of panitumumab to EGFR results in internalisation of the receptor, inhibition of cell growth, induction of apoptosis, and decreased interleukin 8 and vascular endothelial growth factor production.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)In vitro assays and in vivo animal studies have shown that panitumumab inhibits the growth and survival of tumour cells expressing EGFR. No anti-tumour effects of panitumumab were observed in human tumour xenografts lacking EGFR expression. The addition of panitumumab to radiation, chemotherapy or other targeted therapeutic agents, in animal studies resulted in an increase in antitumour effects compared to radiation, chemotherapy or targeted therapeutic agents alone.
Original license holder
Marketing authorisation numbersEU/1/07/423/001
EU/1/07/423/003
Marketing authorisation holderAmgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands
Name of the manufacturer of the biological active substanceImmunex Rhode Island Corporation (ARI)
40 Technology Way
West Greenwich,
Rhode Island
02817
USA
Name and address of the manufacturer(s) responsible for batch releaseAmgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Amgen Technology (Ireland) Unlimited Company
Pottery Road
Dun Laoghaire
Co Dublin
Ireland

Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
Max shelf life
36 months
Storage conditions
2°C – 8°C
List of excipients
Sodium chloride
Sodium acetate trihydrate
Acetic acid, glacial (for pH-adjustment)
Water for injections