U.S. Food and Drug Administration advisers rejected Roche Holding AG’s breast cancer drug, Avastin. They said it was not safe or clinically beneficial. Avastin’s approval as breast cancer medication may be revoked and FDA Commissioner Margaret Hamburg said the final decision is due later. Cleveland Clinic Taussig Cancer Institute professor Mikkael Sekeres who was a member of the FDA panel, said there’s nothing about the drug that makes them comfortable exposing a lot of patients to risk without a clear benefit. The decision could jeopardize the $8,000-a-month Avastin and the ongoing treatment of about 17,000 women. On the decision, a tearful Christi Turnage said she is on Avastin alone, which is keeping her alive without chemo. She has been taking the drug for 8 years. Her HMO warned of stop-coverage for the drug if FDA disapproves it. She said she doesn’t qualify for a single drug trial in the U.S. or Canada because she has no symptoms of disease.
Opinions over the drug are at odds but some will continue coverage. Dr. Leonard Lichtenfeld of the American Cancer Society said the FDA clearly believes there is no evidence of significant benefit in metastatic breast cancer, but other qualified experts are clearly on the other side. Potentially, Roche could lose about $1 billion out of $6 billion Avastin revenue. Other markets continue the use of Avastin for breast cancer and for other indications and does not affect their Roche evaluation overall, said analyst Karen Andersen. She sees U.S. Avastin sales to fall from 2010’s $800 million to $400 this year. Roche asks that Avastin continue to be available to patients as further studies on its clinical benefits are conducted which may take 3.5 years, said FDA officials. Panel member Dr. Ralph Freedman said the FDA has to protect patients and may have to decide against to do so.
When the study said the drug stalled breast cancer growth combined with chemotherapy, it was given approval in 2008. The FDA asked Roche to continue the studies which found that the drug showed no proof of extending the lives of patients with advanced breast cancer. Some suffered brutal side effects but Roche said it was only a total of 3% of Avastin takers. In December, the FDA wanted to revoke Avastin’s use for breast cancer but continue its distribution for colon, lung, brain and kidney cancers.
Genentech’ chief medical officer Dr. Hal Barron said they are very disappointed by the committee’s recommendation and hope the Commissioner does not decide to remove an important medicine for an incurable disease. Despite FDA’s decision, Roche plans to continue follow-up studies and see Avastin’s efficacy when combined with chemotherapy called paclitaxel. They will try to see which patients respond to treatments.