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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 .
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 that time, Erbitux was available experimentally only for patients participating in colon cancer clinical trials. The argument made by the Abigail Alliance in court was that terminal cancer patients have a constitutionally protected right to access to experimental medications before the FDA approves them.
Phase 2 Study Results for Tivantinib in Combination with Cetuximab and Irinotecan for Colorectal Cancer Presented at ASCO 2013 Signals of clinical benefit observed in consistent trends toward ...
Patients included in the study failed treatment with oxaliplatin, and initial safety studies included comparing Abituzumab, cetuximab, and irinotecan with standard of care. The Phase I study showed that doses up to 1000 mg of Abituzumab, cetuximab, and irinotecan were well tolerated.
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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. One ultimately succeeded; the ...
CHART #4: SIDE-BY-SIDE COMPARISON OF REPUBLICAN CANDIDATESÕ HEALTH PLANS By Susan J. Blumenthal, M.D., Jessica B. Rubin, Michelle E. Treseler, Jefferson Lin, and David Mattos*