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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 .
Abigail Burroughs was a college student diagnosed with head and neck cancer. During the later phases of her treatment, Abigail's father, Frank Burroughs, formed an organization, the Abigail Alliance for Better Access to Developmental Drugs and sued the FDA for access to Erbitux.
ImClone's stock price dropped sharply at the end of 2001 when its drug Erbitux, an experimental monoclonal antibody, failed to get the expected Food and Drug Administration (FDA) approval. It was later revealed by the U.S. Securities and Exchange Commission that prior to the announcement (after the close of trading on December 28) of the FDA's ...
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.
Samuel D. Waksal (born September 8, 1947) is the founder and former CEO of the biopharmaceutical company ImClone Systems.He is also the founder of Kadmon Pharmaceuticals, which was financed with private capital and commenced operations in New York City in 2010. [1]
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).
Cetuximab (trade name: Erbitux ) is a recombinant chimeric monoclonal antibody designed to treat metastatic colorectal cancer and head and neck cancer. [14] In numerous cancers, the epidermal growth factor receptor (EGFR) is often inappropriately activated and overexpressed in cancer cells, leading to uncontrolled cell growth. [15]
Erbitux was in development as a cancer therapeutic drug by the pharmaceutical company ImClone Systems, Inc. Paul Goldberg documented the missteps in FDA filings by ImClone that led to the failure to secure proper licensing for the drug and the subsequent precipitous drop in the value of ImClone stock.