The US Food and Drug Administration (FDA) has begun its process to remove the breast cancer indication from bevacizumab’s (Avastin, Genentech) label. Its decision to move forward is based on a recommendation by it advisory committee composed mainly of oncology.
Removing the indication involves a process, of which this is only the first step. During this process, the drug will remain on the market and with it breast cancer indication intact. The drugs other indications—colon, kidney, brain, and lung cancers—are not affected by this decision.
Genentech has announced that it plans to request a hearing to state its case for keeping the indication.
The FDA’s advisory committee reviewed all available data from trials of bevacizumab in women with breast cancer, determining that bevacizumab did not prolong overall survival or provide significant slowing of disease progression in comparison to the agent’s risks.
“None of the four trials showed any survival benefit. They did not show that adding Avastin to a variety of chemotherapy regimens prolongs the life of women with metastatic breast cancer, but added many serious side effects,” said Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research at a news briefing.
Read the FDA press release:
ttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237172.htm
ttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237172.htm
Read our coverage from August:
http://www.theoncologynurse.com/article/physicians-patients-react-fda-committee-vote-against-bevacizumab-breast-cancer
http://www.theoncologynurse.com/article/physicians-patients-react-fda-committee-vote-against-bevacizumab-breast-cancer