After months of debate, the FDA is officially revoking its approval of Avastin as an effective breast cancer treatment, according to a Nov. 18 news release.
The embattled cancer drug failed to show its benefits outweighed risks, including high blood pressure and heart failure, or improve quality of life in clinical trials, the FDA cites in the release.
“This was a difficult decision…but patients must have confidence that the drugs they take are both safe and effective for their intended use,” FDA Commissioner Margaret Hamburg, M.D., said in the release.
Remember: CMS already announced it would continue coverage for Avastin’s off-label breast cancer treatment use and start covering for Provenge (sipulecel-T), an immunotherapy treatment for prostate cancer on June 30 (PBN 7/16/11). “Medicare will continue to cover Avastin...CMS will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies,” CMS says in an email to Part B News.
NOTE: Avastin is still approved for treating colon, lung, kidney and brain cancers.