VECTIBIX
Vectibix (panitumumab) is a recombinant, human IgG2 kappa monoclonal antibody that binds specifically to the human epidermal growth factor receptor (EGFR). Panitumumab has an approximate molecular weight of 147 kDa.
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US pre-BLA |
May 12, 2005 |
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US Approval |
September 27, 2006 |
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EU Approval |
December 3, 2007 |
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Health Canada Approval |
December 12, 2008 |
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TGA |
May 7, 2012 |
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PARAMETER |
DATA |
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Manufacturer |
Amgen Incorporated |
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Indication |
Vectibix is an epidermal growth factor receptor antagonist indicated as a single agent for the treatment of metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens. Approval is based on progression-free survival; no data demonstrate an improvement in disease-related symptoms or increased survival with Vectibix. |
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Cell Substrate |
Genetically engineered mammalian (Chinese Hamster Ovary) cells. |
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Manufacturing platform |
Panitumumab is produced from Chinese Hamster Ovary (CHO) cells and purified by a series of chromatography steps, viral inactivation step, viral filtration step and ultrafiltration/diafiltration steps. The expression plasmid containing the genes for the heavy and light chains was transfected into CHO cells. Following cloning and sub-cloning steps, one clone producing panitumumab at high levels was selected as lead cell line. A two-tiered cell banking system of Master Cell bank (MCB) and Working Cell Bank (WCB) has been developed and maintained in accordance to cGMP and ICH guidelines. |
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Dose in vial/final container |
Single-use vials (20 mg/mL): 100 mg/5 mL, 200 mg/10 mL, 400 mg/20 mL. |
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Dose to patient |
6 mg/kg every 14 days as an intravenous infusion over 60 minutes (≤ 1000 mg) or 90 minutes (> 1000 mg) |
CLINICAL TRIALS
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NCT |
TRIAL PHASE |
NO OF PATIENTS ENROLLED |
STUDY TITLE |
COUNTRIES |
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Monotherapy (mCRC) |
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NCT00113763 |
3 |
463 |
– |
|
|
NCT00113776 |
2 |
– |
Evaluating ABX-EGF Extended Therapy in Subjects with Metastatic Colorectal Cancer |
– |
|
NCT00083616 |
2 |
185 |
– |
|
|
NCT00089635 |
2 |
203 |
Panitumumab (ABX-EGF) Monotherapy in Patients with Metastatic Colorectal Cancer |
– |
|
NCT00111774 |
2 |
150 |
Evaluating ABX-EGF in Patients with Metastatic Colorectal Carcinoma |
– |
|
Solid Tumors |
||||
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NCT00425204 |
2 |
31 |
Study for Patients Who Have Benefited and Tolerated Prior Panitumumab Treatment |
– |
|
NCT00091806 |
1 |
86 |
Two Dose Schedules of Panitumumab in Subjects with Advanced Solid Tumors |
– |
|
NCT00101920 |
2 |
50 |
ABX-EGF as Second Line Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC) |
– |
|
NCT00425035 |
2 |
115 |
Safety and Efficacy Study of ABX-EGF in Patients with Renal Cancer, Part 2 |
– |
|
Combination Therapy |
||||
|
NCT00111761 |
2 |
43 |
Evaluating Panitumumab (ABX-EGF) in Patients with Metastatic Colorectal Cancer |
– |
|
NCT00034346 |
2 |
194 |
– |
|