Genentech Fails to Sway FDA Panel

An FDA advisory panel voted 12-1 today against the usage of Genentech’s bevacizumab (Avastin) as a treatment for women with certain forms of breast cancer. The Oncologic Drugs Advisory Committee recommended that the FDA remove language from the drug’s prescribing information that states it can be used for women getting their first round of treatment for breast cancers that don’t have overexpressed forms of a protein called HER2. The FDA’s deadline to make its decision on the matter is Sept. 17. While the agency doesn’t always follow the advice of its panels, it usually does. “We are disappointed by the committee’s recommendation and believe Avastin should be an option for women with this incurable disease,” said Sandra Horning, a Genentech senior vice president, in a statement. Avastin is currently approved by the FDA to treat lung, colorectal, brain, kidney, and breast cancers.

Author: Luke Timmerman

Luke is an award-winning journalist specializing in life sciences. He has served as national biotechnology editor for Xconomy and national biotechnology reporter for Bloomberg News. Luke got started covering life sciences at The Seattle Times, where he was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award and several other national prizes. Luke holds a bachelor’s degree in journalism from the University of Wisconsin-Madison, and during the 2005-2006 academic year, he was a Knight Science Journalism Fellow at MIT.