Jul 16, 2010 2:45 PM by Dr. Anya Winslow
Federal health scientists say follow-up studies of the breast cancer drug Avastin show it did not slow tumor growth to the same degree as reported in earlier studies or extend patient lives.
The Food and Drug Administration gave Roche's blockbuster drug conditional approval two years ago based on early-stage trials showing it shrank tumors caused by breast cancer. Such drugs are usually required to show increased survival time for patients.
The FDA says two follow-up studies recently submitted by the drugmaker did not show that Avastin extended lives compared to chemotherapy alone. It also says recent data has not confirmed the tumor shrinkage seen in earlier studies.
And patients taking Avastin showed significantly more side effects, including high blood pressure, fatigue and abnormal white blood cell levels.
On Tuesday the FDA will ask a panel of outside cancer experts to review the evidence on Avastin. The agency has the option of removing the drug's approval for breast cancer.
The FDA has also approved Avastin for colon, lung, kidney and brain cancer.
For treatment choices based on the latest scientific research, contact the Dorcy Cancer Center at St. Mary-Corwin Medical Center in Pueblo.
5 hours ago