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Cetuximab, sold under the brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor medication used for the treatment of metastatic colorectal cancer and head and neck cancer. [2] Cetuximab is a chimeric (mouse/human) monoclonal antibody given by intravenous infusion .
The FDA approved the aforementioned colorectal cancer drug, Erbitux, on February 12, 2004.In May 2001, while ImClone was still seeking approval for the drug (then known as IMC-C225), the CBS news program "60 Minutes" aired a story about two cancer patients' struggles to obtain "compassionate use" of the drug.
Examples of chimeric antibodies approved for human therapy include abciximab (ReoPro), basiliximab (Simulect), cetuximab (Erbitux), infliximab (Remicade) and rituximab (MabThera). There are also several examples of chimerics currently in clinical trials (e.g. bavituximab, see sortable list for additional examples).
In July 2009, the FDA updated the labels of two anti-EGFR monoclonal antibody drugs (panitumumab and cetuximab) indicated for the treatment of metastatic colorectal cancer to include information about KRAS mutations. [14] This was the result of a study, which demonstrated lack of benefit with Panitumumab in patients who carried NRAS mutations. [6]
At ImClone, Waksal led the company to develop the cancer drug Erbitux (cetuximab). During the course of its review process with the Food and Drug Administration (FDA) Waksal became involved in an insider trading scandal revolving around improper communications with personal friends and family members. He was convicted of several securities ...
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In oncology, its first marketed product is Erbitux , for which it has marketing rights worldwide, apart from North America. [60] (Cetuximab was discovered by Imclone Systems, and is marketed in North America by Bristol-Myers Squibb.) Other areas of Expertise from Merck Healthcare include Fertility, Endocrinology and General Medicine, the later ...