FDA Approves ImClone's Erbitux
Erbitux is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.
Erbitux is used to treat cancers of the colon and rectum. It is also used to treat head and neck cancer. It may be used alone or along with radiation treatments or other medicines.
Patients with head and neck cancer appear to survive nearly twice as long after receiving a new drug known as Erbitux (scientific name: cetuximab) in conjunction with radiation therapy compared with patients treated solely with radiation therapy.
In findings announced at the American Society of Clinical Oncology (ASCO) 2004 Annual Meeting, Paul M. Harari, a UW Comprehensive Cancer Center radiation oncologist, said the findings of the phase III international study are highly promising.
Erbitux (cetuximab) for injection is a monoclonal antibodyt hat targets and inhibits epidermal growth factor receptor (EGFr). EGFr is over-expressed in more than 35% of all solid malignant tumors. It is used alone or combination with other therapies for the treatment of colorectal cancer.
Erbitux is indicated, in combination with irinotecan, for the treatment of EGFR-expressing, metastatic colorectal cancer in patients who are refractory to irinotecan-based chemotherapy. In addition, it is also approved for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy.
The U.S. Food and Drug Administration (FDA) has approved the drug cetuximab, known as Erbitux, for the treatment of advanced colorectal cancer. Studies have shown that Erbitux can shrink tumors and delay tumor growth, but it is not known if treatment will improve symptoms or help patients live longer.
Erbitux, developed by ImClone Systems Incorporated, is the first monoclonal antibody approved for treatment of colorectal cancer. It will be used in patients who are no longer responding to or cannot take the chemotherapy drug irinotecan. Erbitux works by blocking a type of protein called epidermal growth factor receptor (EGFR); the action deprives tumors of an element they need to grow. The FDA also has approved a test kit to help doctors determine which patients have these receptors and are therefore eligible for the treatment.