Decision Resources, Inc., one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, reports that the FDA's Oncologic Drugs Advisory Committee (ODAC) voted against Genentech/Roche's Avastin for first-line treatment of breast cancer in December 2007. According to the new Macroview update, the FDA's ODAC voted 5 to 4 that data are insufficient to recommend Avastin for approval for first-line treatment of metastatic or recurrent breast cancer.
The ODAC said that in the absence of a benefit in overall survival, Avastin's 5.5 month improvement in progression-free survival does not outweigh the risks associated with the drug.
An August 2007 survey by Decision Resources found that a very high rate of oncologists prescribing Avastin off-label to treat metastatic breast cancer.
"In August of 2007, 79 percent of U.S. oncologists were using Avastin to treat breast cancer patients," said Mary Fletcher-Louis., director at Decision Resources. "This prescribing behavior is driven by familiarity with Avastin for colorectal cancer and non-small-cell lung cancer, and by approval of this agent for breast cancer in Europe."
The FDA is not bound by the ODAC vote, and will make its final decision by February 23, 2008. For commentary on the final vote, please contact Elizabeth Marshall at 781-296-2563 to schedule an interview with Dr. Argent-Katwala.
About Macroview from Decision Resources
Macroview is the most up-to-date analysis on events impacting the healthcare industry. The Macroview updates are part of Decision Resources' Pharmaview product line, which offers a thorough analysis of the biopharmaceutical sector from a therapy, industry and company point-of-view.
About Decision Resources
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SOURCE: Decision Resources, Inc.
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