Cetuximab: Difference between revisions
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'''Erbitux®''' is one of the most expensive drugs available, costing over $17,000 per month for the average dose. |
'''Erbitux®''' is one of the most expensive drugs available, costing over $17,000 per month for the average dose. |
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March 1, 2006 |
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Erbitux was recently approved for treatment of head and neck cancer. |
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The Food and Drug Administration (FDA) today announced the approval of Erbitux (cetuximab) for use in combination with radiation therapy to treat patients with squamous cell cancer of the head and neck (SCCHN) that can not be removed by surgery (unresectable SCCHN). This is the first drug approved for head and neck cancer that has shown a survival benefit in this population. Erbitux was also approved today for use alone (monotherapy) to treat patients whose head and neck cancer has spread (metastasized) despite the use of standard chemotherapy |
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http://www.fda.gov/bbs/topics/NEWS/2006/NEW01329.html |
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Addition of Erbitux® to Radiation Improves Survival in Locally Advanced Head and Neck Cancer |
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According to results presented at the 40th annual meeting of the American Society of Clinical Oncology (ASCO), the addition of Erbitux® (cetuximab) to high-dose radiation therapy improves the average duration of survival compared to high-dose radiation therapy alone in the treatment of locally advanced head and neck cancer. |
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Approximately 40,000 people in the United States are diagnosed with head and neck cancer every year. Cancers of the head and neck comprise several types of cancer, including the nasal cavity and sinuses, oral cavity, nasopharynx, oropharynx, and other sites located in the head and neck area. Locally advanced head and neck cancer refers to cancer that has spread locally from its site of origin to surrounding tissues, but not to distant sites in the body. Standard treatment for locally advanced head and neck cancer often consists of chemotherapy and radiation therapy and possible surgery. Researchers continue to evaluate and compare different treatment regimens or novel therapeutic approaches to improve survival and quality of life in patients with head and neck cancer. |
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One novel targeted therapeutic approach includes the agent Erbitux®, which is a monoclonal antibody targeted against the EGFR. The EGFR pathway is involved in the growth and replication of cells, and is often overexpressed in cancer cells. Erbitux® has been designed through laboratory processes to bind to the EGFR on the outer surface of cancer cells. This binding action is believed to prevent or reduce the replication of the cancer cells, resulting in anti-cancer responses. Erbitux® is currently approved in the treatment of advanced colorectal cancer, and is in several clinical trials evaluating its efficacy in the treatment of various cancers. |
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==External links== |
==External links== |
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* [http://www.fda.gov/cder/drug/infopage/erbitux/default.htm FDA Erbitux (cetuximab) Information Page] |
* [http://www.fda.gov/cder/drug/infopage/erbitux/default.htm FDA Erbitux (cetuximab) Information Page] |
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* [http://www.erbitux.com/ Erbitux site from Bristol-Myers Squibb, ImClone Systems, and Merck KGaA ] |
* [http://www.erbitux.com/ Erbitux site from Bristol-Myers Squibb, ImClone Systems, and Merck KGaA ] |
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http://patient.cancerconsultants.com/head_cancer_news.aspx?id=30708 |
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[[Category:Cancer treatments]] |
[[Category:Cancer treatments]] |
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Revision as of 15:13, 18 July 2006
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| Legal status | |
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| Legal status | |
| Pharmacokinetic data | |
| Elimination half-life | 114 hrs |
| Identifiers | |
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| CAS Number | |
| DrugBank | |
| CompTox Dashboard (EPA) | |
| Chemical and physical data | |
| Formula | C6484H10042N1732O2023S36 |
| Molar mass | 145781.6 g/mol |
Cetuximab (Erbitux®) is a chimeric monoclonal antibody given by intravenous injection for treatment of metastatic colorectal cancer and head and neck cancer.
Cetuximab is distributed inside the United States by ImClone Systems and Bristol-Myers Squibb, while it is distributed outside North America by Merck KGaA. It faces stiff competition from bevacizumab (Avastin), made by Genentech, and potential competition from a new drug currently under development by Abgenix.
Mode of action
Cetuximab is believed to operate by locking onto the epidermal growth factor receptors (EGFR) of cancer cells. This prevents normal epidermal growth factors from stimulating cell growth and repair.
Clinical uses
Cetuximab is used in metastatic colon cancer and is given concurrently with the chemotherapy drug irinotecan (Camptosar®), a form of chemotherapy that blocks the effect of DNA topoisomerase I, resulting in fatal damage to the DNA of affected cells. While there is a medical laboratory test to detect if a cancer tumor over expresses epidermal growth factor receptor(EGFR) on its cells surface, this over expression has recently been shown to not have any bearing on whether a patient will respond to Cetuximab or not. Whether this is because the current tests are just not sensitive enough to detect EGFR over expression or EGFR over expression is not linked to the drugs effectiveness has not been established. Cetuximab was approved by the FDA in March 2006 after the publication of research performed by Dr J Bonner [1] for use in combination with radiation therapy for treating squamous cell carcinoma of the head and neck (SCCHN) or as a single agent in patients who have had prior platinum-based thearpy.
The probability of successfully responding to Cetuximab therapy is linked to the incidence of ache like rash, one of the drugs side effects. The worse the rash that develops for the patient the higher the response rate.
ImClone insider trading scandal
The initial failure of ImClone Systems to prepare an acceptable FDA filing led to the infamous Martha Stewart insider trading scandal when ImClone's CEO sold ImClone shares and this information was leaked to Martha before the FDA announced its refusal to approve the drug for public use. Martha Stewart, Samuel D. Waksal (the founder and former CEO of ImClone), and their broker were indicted, and Stewart and Waksal were sentenced to prison. ImClone shares dropped sharply in the aftermath of the insider trading scandal.
A new clinical trial and FDA filing prepared by Imclone's partner Merck KGaA ("German Merck," not to be confused with the US company of similar name) resulted in an FDA approval of the drug in 2004 for use in colon cancer.
Erbitux® is one of the most expensive drugs available, costing over $17,000 per month for the average dose.
March 1, 2006 Erbitux was recently approved for treatment of head and neck cancer. The Food and Drug Administration (FDA) today announced the approval of Erbitux (cetuximab) for use in combination with radiation therapy to treat patients with squamous cell cancer of the head and neck (SCCHN) that can not be removed by surgery (unresectable SCCHN). This is the first drug approved for head and neck cancer that has shown a survival benefit in this population. Erbitux was also approved today for use alone (monotherapy) to treat patients whose head and neck cancer has spread (metastasized) despite the use of standard chemotherapy http://www.fda.gov/bbs/topics/NEWS/2006/NEW01329.html
Addition of Erbitux® to Radiation Improves Survival in Locally Advanced Head and Neck Cancer
According to results presented at the 40th annual meeting of the American Society of Clinical Oncology (ASCO), the addition of Erbitux® (cetuximab) to high-dose radiation therapy improves the average duration of survival compared to high-dose radiation therapy alone in the treatment of locally advanced head and neck cancer.
Approximately 40,000 people in the United States are diagnosed with head and neck cancer every year. Cancers of the head and neck comprise several types of cancer, including the nasal cavity and sinuses, oral cavity, nasopharynx, oropharynx, and other sites located in the head and neck area. Locally advanced head and neck cancer refers to cancer that has spread locally from its site of origin to surrounding tissues, but not to distant sites in the body. Standard treatment for locally advanced head and neck cancer often consists of chemotherapy and radiation therapy and possible surgery. Researchers continue to evaluate and compare different treatment regimens or novel therapeutic approaches to improve survival and quality of life in patients with head and neck cancer.
One novel targeted therapeutic approach includes the agent Erbitux®, which is a monoclonal antibody targeted against the EGFR. The EGFR pathway is involved in the growth and replication of cells, and is often overexpressed in cancer cells. Erbitux® has been designed through laboratory processes to bind to the EGFR on the outer surface of cancer cells. This binding action is believed to prevent or reduce the replication of the cancer cells, resulting in anti-cancer responses. Erbitux® is currently approved in the treatment of advanced colorectal cancer, and is in several clinical trials evaluating its efficacy in the treatment of various cancers.
External links
- FDA Erbitux (cetuximab) Information Page
- Erbitux site from Bristol-Myers Squibb, ImClone Systems, and Merck KGaA
http://patient.cancerconsultants.com/head_cancer_news.aspx?id=30708
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.