U.S. FDA revokes Avastin as breast cancer treatment

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U.S. FDA revokes Avastin as breast cancer treatment

2011-11-19 10:30:28 GMT+7 (ICT)

MARYLAND (BNO NEWS) -- The U.S. Food and Drug Administration (FDA) has revoked the approval of Avastin, one of the world's best-selling cancer drug, for breast cancer treatment, the agency announced on Friday.

The commissioner of the FDA, Margaret Hamburg, said the drug has not been shown to be safe and effective when used to combat breast cancer. However, Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer.

"This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments," Dr. Hamburg said. "But patients must have confidence that the drugs they take are both safe and effective for their intended use."

Hamburg also said that the use of the drug may produce dangerous side effects, including severe high blood pressure, bleeding and hemorrhaging, heart attack, and perforations in different parts of the body. Tests have also shown that there is no proof that the use of Avastin extends the lives of patients or improves their quality of life, she said.

Avastin was approved for metastatic breast cancer in February 2008 under the FDA's accelerated approval program. The program provides earlier patient access to promising new drugs while confirmatory clinical trials are conducted.

After the accelerated approval of Avastin for breast cancer, the drug's sponsor, Genentech, a subsidy of the Swiss pharmaceutical Roche, completed two additional clinical trials and submitted the data from those studies to the FDA. However, the agency ultimately concluded to withdraw approval of the drug. 

Genentech did not agree with the agency's decision and said it will conduct new tests on the drug. "We are disappointed with the outcome," said Hal Barron, chief medical officer and head of Global Product Development at Genentech. "We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States."

Barron added: "Despite today's action, we will start a new Phase III study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin."

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