The Avastin decision: Science, emotion, and politics collide

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After an FDA advisory panel unanimously voted in June to revoke the approval of the drug Avastin as a treatment for advanced breast cancer, FDA commissioner Dr. Margaret A. Hamburg announced last week that the agency will support the committee s recommendation and rescind approval.

The Genentech (now part of Roche) drug has experienced a rocky road ever since it was originally granted expedited, but conditional approval, by the FDA in December 2007. Initial trials indicated that Avastin did not significantly increase longevity among patients with advanced breast cancer when combined with the chemotherapy drug placlitaxel (Taxol). Despite the lackluster study results, the agency still granted the drug provisional approval two months later as part of its accelerated approval process albeit with the caveat that Genentech would provide follow-up studies to demonstrate the drug s efficacy. In July 2010, however, an FDA cancer advisory panel once again recommended that the approval be revoked. Genentech requested another hearing in June 2011, during which the drugmaker presented more supportive data. Despite their pleas, Dr. Hamburg decided to revoke the drug s breast cancer approval, stating that, in addition to posing serious side effects, such as severe high blood pressure and hemorrhaging, Avastin does not demonstrate sufficient evidence of increasing longevity or improving patients quality of life.

Doctors, however, can still prescribe the drug off-label for women with breast cancer, since Avastin is still approved as a treatment for other forms of cancer. However, since some insurance companies will probably no longer cover its expense, the drug s price tag of $88,000 annually may put it out of reach for many women. Despite the FDA s decision, Medicare and UnitedHealthcare both stated they would continue to pay for Avastin treatment for advanced breast cancer, while Genentech announced they also would assist patients in covering the cost of the drug.

From a clinician s perspective, ACSH s Dr. Gilbert Ross says the FDA s latest decision will undoubtedly cut down Avastin s use, since, if nothing else, doctors who might normally prescribe the drug will now have to think twice due to potential financial implications for patients, and also because they may now be susceptible to lawsuits when using Avastin off-label. He adds, Though the stark population studies indicate that Avastin does not help breast cancer patients live longer, a small number of women on the drug do seem to have better outcomes. But unfortunately, there s no way to predict who these women will be.

Interestingly, Japan just approved Avastin for the treatment of breast cancer in September, and the drug remains on the market for the same indication in Europe as well.