Avastin and breast cancer

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Bevacizumab Avastin; Genentech for metastatic breast cancer may be one of the most widely debated, media-reported, and editorialized agents in oncology. This is certainly understandable in an era when targeted therapy such as bevacizumab, a monoclonal antibody against the vascular endothelial growth factor, holds high expectations to provide a much-needed treatment option for thousands of women with metastatic breast cancer. The most important and most contested question concerns what is an appropriate, clinically significant end point in clinical trials of new agents to decide their FDA approval: progression free survival PFS or overall survival OS.

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Avastin was approved in advanced breast cancer under the FDA's accelerated approval program, which allows the FDA to approve products for cancer or other life-threatening diseases based on initial positive clinical data. As a part of our commitment to fully evaluate Avastin in breast cancer, Genentech will also submit data to the FDA from three additional randomized trials that are either ongoing or planned. According to the American Cancer Society, an estimatedwomen were diagnosed with breast cancer and approximately 40, died from the disease in the U.

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Disclosures: Ricardo H. Significant advances in the treatment of patients with breast cancer have been made in the past 10 years. The current systemic treatment of breast cancer is characterized by the discovery of multiple cancer targets leading to treatments that are more sophisticated and specific than conventional cytotoxic chemotherapy.

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The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancerruling on an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials. The commissioner, Dr. Margaret A.

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What is bevacizumab? How does bevacizumab work? Who might be offered bevacizumab?

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Outline the data from clinical trials of bevacizumab conducted in patients with breast cancer. Discuss the interpretation of the phase III study of capecitabine alone or in combination with bevacizumab. Vascular endothelial growth factor VEGF has emerged as a key target for the treatment of cancer.

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Metastatic breast cancer MBC is a major cause of death among women worldwide. Progress has been made in treating MBC with the advent of anti-estrogen therapies, potent cytotoxic agents, and monoclonal antibodies. The FDA then reversed this decision in December by recommending removal of the MBC indication from bevacizumab, citing primarily safety concerns, and that these risks did not outweigh the ability of bevacizumab to significantly prolong progression-free survival. This decision was unexpected in the oncology community and remains controversial.

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Avastin chemical name: bevacizumab is a targeted therapy that was approved by the U. Food and Drug Administration FDA in combination with Taxol chemical name: paclitaxel in February to treat people with metastatic HER2-negative breast cancer who haven't yet received chemotherapy for metastatic breast cancer. On Nov. The medicine itself is not being removed from the market and doctors can choose to use Avastin to treat metastatic breast cancer whether or not that particular use is officially approved by the FDA.

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