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Based on our Pharmacor advisory service entitled Breast Cancer, Decision Resources is offering an exclusive analyst call entitled A Crushing Blow for Avastin? Assessing the Impact of an FDA Panel’s 12 to 1 Vote to Withdraw Avastin’s Marketing Approval for Breast Cancer. Because this presentation will feature major updates, it is ONLY available to purchasers of this Pharmacor advisory service. Please contact us to learn how you can purchase this Pharmacor advisory service and attend the analyst call. The dominant position in breast cancer for the world's best-selling oncology drug, Roche/Genentech/Chugai’s Avastin, is under significant threat following the recent recommendation by the FDA’s Oncologic Drugs Advisory Committee (ODAC) to withdraw Avastin’s marketing approval for HER2-negative metastatic breast cancer. By a 12 to 1 margin, the ODAC voted against Avastin’s full approval in this indication because it failed to demonstrate an improvement in overall survival or an improvement in patients’ quality of life in the AVADO and RIBBON-1 Phase III clinical trials. At the time of Avastin’s initial conditional approval in metastatic breast cancer, the FDA stipulated that full approval would depend on a review of both of these pivotal trials. Although data from both trials demonstrated an improvement in progression-free survival (the primary end point), Avastin’s failure to show an improvement in overall survival was a monumental setback for the drug. Avastin, which garnered nearly $6 billion in sales in 2009, received accelerated approval from the FDA in February 2008 as a first-line treatment for HER2-negative metastatic breast cancer. This approval was based on improvements on progression free survival and overall response rates in the E2100 Phase III clinical trial. Due to high unmet need in the indication, Avastin had enjoyed significant uptake, with breast cancer emerging as one of its top earners. In the United States alone, Avastin garnered sales of more than $770 million in 2009 for the treatment of metastatic breast cancer. The FDA is expected to make a final decision regarding Avastin’s future in breast cancer by September 17, 2010. This 15-minute analyst call, presented by Decision Resources Analyst Niamh Murphy, Ph.D., will answer the following questions:
Dr. Murphy will conduct a live Q & A session after the presentation. Registration A Crushing Blow for Avastin? Assessing the Impact of an FDA Panel’s 12 to 1 Vote to Withdraw Avastin’s Marketing Approval for Breast Cancer July 29, 2010 at 10 a.m. U.S. Eastern Time, 4 p.m. Central European Time (Paris). To learn how you can purchase this Pharmacor advisory service and attend the analyst call, please contact us using the information below. In North America — Keith Rourke at 781-296-2656 or krourke@dresources.com |
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Niamh Murphy, Ph.D., is an analyst on the oncology team at Decision Resources. Dr. Murphy obtained an honors degree in biotechnology and a Ph.D. on the molecular biology of cervical cancer from Trinity College in Ireland. She worked as a postdoctoral scientist for several years, during which time she was involved in several international translational breast cancer research projects. Most recently, she analyzed drug resistance and chromosomal instability in breast cancer. Dr. Murphy authored numerous peer-reviewed papers and abstracts and presented data at international cancer conferences.