Wednesday’s unprecedented vote by an FDA panel of cancer experts has decided for the second time that Roche’s, Avastin, should no longer be used as a treatment for breast cancer. The panel’s decision clears the way for the U.S. Food and Drug Administration to revoke its previous fast-track endorsement of the drug.

In three unanimous votes, the panel of oncology experts voted against Avastin, citing that use of the drug as a treatment for breast cancer is both ineffective and unsafe. While the panel’s recommendation will be heavily weighed by the FDA, the drug’s true fate rests in the hands of agency Commissioner, Margaret Hamburg. Hamburg is responsible for making the final decision regarding whether or not to suspend the marketing efforts of the drug’s indication for breast cancer.

The FDA began taking steps to revoke Avastin’s approval as a breast cancer treatment in December, but drug maker, Roche, did not back down without a fight. The company went to great lengths to appeal the FDA’s decision for revocation and heavily lobbied Congressional leaders in order to secure a second hearing on the matter.

The dramatic conclusion of the two-day, trial-like hearing highlighted the difficulty associated with the removal of drug options for cancer patients, even when scientific evidence supported a recommendation for withdrawal. Following the announcement of the panel’s decision, patients in the audience erupted with disapproval.

Should the FDA follow-through with the withdrawal of Avastin, Roche, could lose up to $1 billion in revenue. The drug generates approximately $6 billion for the company each year, as its use is approved for the treatment of lung, kidney, colon and brain cancer. Even if the drug loses its indication for breast cancer, doctors can still prescribe it to patients, but insurers may not pay for its use as an “off-label” treatment option.


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