YERVOY (ipilimumab) is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). Ipilimumab is an IgG1 kappa immunoglobulin with an approximate molecular weight of 148 kDa.
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PARAMETER |
DATA |
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Manufacturer |
Bristol-Myers Squibb Company |
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Indication |
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma. |
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Cell Substrate |
CHO cell line |
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Manufacturing platform |
Ipilimumab is produced as a secreted protein in large-scale cell culture employing a CHO cell line that was transfected with an expression vector containing the coding sequences for both heavy and light chains of ipilimumab. This cell line is maintained with a Master Cell Bank and a Working Cell Bank (WCB) both of which have been tested consistent with ICH guidance documents. |
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Dose in vial/final container |
50 mg/10 mL (5 mg/mL). 200 mg/40 mL (5 mg/mL). |
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Dose to patient |
3 mg/kg administered intravenously over 90 minutes every 3 weeks for a total of four doses |
CLINICAL TRIALS
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NCT |
TRIAL PHASE |
NO OF PATIENTS ENROLLED |
TITLE |
COUNTRIES |
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Primary efficacy and safety study |
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NCT00094653 |
3 |
1783 |
United States, Chile, Belgium, Brazil, Canada, France, Germany, Hungary, Argentina, Netherlands, South Africa, Switzerland, United Kingdom |
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Other efficacy study of interest |
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NCT00324155 |
3 |
681 |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Spain, Chile, France, Israel, Germany, Italy, Hungary, Ireland, Czech Republic, Poland, Norway, Portugal, Netherlands, Russian Federation, South Africa, Switzerland, Ukraine, United Kingdom |
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Other studies |
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NCT00289640 |
2 |
210 |
United States, Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hungary, South Africa |
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NCT00289627 |
2 |
155 |
United States, Italy, Austria, Finland, Norway, Poland, Russian Federation, Spain, Sweden, Ukraine |
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NCT00135408 |
2 |
115 |
A Study of MDX-010 (BMS-734016) Administered with or Without Prophylactic Oral Budesonide |
United States, Peru, Canada, Israel, Italy, United Kingdom |
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NCT00261365 |
1, 2 |
80 |
Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010) |
United States, Peru, Denmark, Israel, Italy, Norway, Sweden |
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NCT00050102 |
2 |
- |
United States |
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NCT00623766 |
2 |
99 |
Evaluation of Tumor Response to Ipilimumab in the Treatment of Melanoma with Brain Metastases |
United States |
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NCT00928031 |
- |
160 |
United States |
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US pre-IND |
April 25, 2008 |
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US Approval |
March 25, 2011 |
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EU Approval |
July 12, 2011 |
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Health Canada Approval |
February 1, 2012 |
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TGA |
June 27, 2011 |
Advice regarding the approvability of this application was not sought from the Oncologic Drugs Advisory Committee Since demonstration of overall survival in two controlled, clinical trials provided sufficient evidence of clinical benefit, particularly in this malignancy where there is currently no highly effective treatment. evidence of improved survival also provides assurance that the benefits generally outweigh the risk.