Roche’s Avastin Loses Approval

In a recent decision by the United States Food and Drug Administration, the approval for the breast cancer drug Avastin was revoked earlier today.

Avastin , the drug used for treatment of breast cancer was developed by the drug manufacturer Genentech which was later on acquired by  Roche Holdings Limited (PINK:RHHBY) has shown no proof of extending the patients’ lives  and it also causes dangerous side effects in the patients.

The revocation of FDA approval for Avastin was long due as the advisory panel of Food and Drug Administration had already unanimously voted to revoke the approval of Avastin in June over the concerns about the side effects. One of the panel members said that even though everyone wanted the drug to succeed and improve the lives of breast cancer patients, the studies on Avastin did not bear out that hope. Avastin was not found to help the patients either live longer or control the tumors and the potentially serious side effects included severe high blood pressure and hemorrhaging.

According to the ruling, Avastin will continue to be available in the market as a treatment for other types of cancer and the doctors can also recommend Avastin for off-label usage to treat breast cancer. But after FDA revoked the approval for breast cancer treatment, few insurers may refuse pay for the drug as a part of the breast cancer treatment, which will cost around $88,000 a year for the patients. Medicare in a statement said that it will continue to pay for the use of Avastin in breast cancer treatment. This decision by FDA comes as a huge setback for the manufacturer, Genentech which strived for long to keep the approval.

According to the estimates, the loss of approval for breast cancer treatment will cost Roche about $1 billion in sales and Avastin has lost its status of being the world’s best selling cancer drug to Rituxan manufactured by Roche itself. Rituxan is used for the treatment of lymphoma.

The commissioner of Food and Drug Administration, Dr. Margret Hamburg said that the decision to revoke te approval was difficult but was necessary as it is necessary the patients have confidence in the drugs which are sold for the treatment of their conditions to be effective. Earlier in 2008, the agency had granted an accelerated approval for Avastin based on a study which showed that the growth of breast cancer tumor was slowed down for more than five months with the drug administered in combination with chemotherapy, but in follow up studies the delay was less than three months.

Post Written By: Ed Liston Ed Liston is a senior contributing editor at TheStockMarketWatch.com. An active market watcher and investor, Ed guides an independent team of experienced analysts and writes for multiple stock trader publications. He is widely quoted in various financial publications on the Internet. When Ed is not writing about stocks, investing in stocks, talking about stocks, or otherwise doing something stock related, he likes to go sailing and fishing in his yacht.