FDA panel votes to revoke approval for Avastin for advanced breast cancer

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The Oncologic Drugs Advisory Committee, FDA, USA disapproved the Avastin which cited a lack of survival benefit. Now as two more trials have been analyzed — neither showing a survival benefit — the FDA stated that in the balance, the benefit did not outweigh the harm.

Terry Kalley, founder of the Freedom of Access to Medicines (FAMEDS), condemned the decision, saying, “While this vote is disappointing, it wasn’t unexpected, because of the six voting members on today’s panel, five of them are already on record as opposing the continued use of Avastin for treatment of breast cancer.”

Kalley, whose wife has late stage breast cancer and has been immensely helped by Avastin, criticized the FDA panel’s makeup as lacking expertise in the area of breast cancer.

Most important point noted is that this FDA panel that has passed judgment on a life or death matter with breast cancer should have been made up of breast cancer specialists and oncologists, but it had zero breast cancer specialists or oncologists on it.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that, during a U.S. Food and Drug Administration (FDA) hearing, the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA withdraw its approval of Avastin? (bevacizumab) in combination with paclitaxel chemotherapy for previously untreated (first-line) HER2-negative metastatic breast cancer. The committee’s recommendation is not the final decision and Avastin plus paclitaxel is still FDA approved for women with HER2-negative metastatic breast cancer. The FDA Commissioner will make the final decision on whether Avastin should remain approved for metastatic breast cancer. The FDA has not announced when the Commissioner will make the final decision.

“We are very disappointed by the committee’s recommendation and hope the Commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin.”

These proceedings and the ODAC’s recommendation have no impact on Avastin’s approved uses for other cancer types in the United States or the use of Avastin for metastatic breast cancer in other countries.

Until the FDA Commissioner makes the final decision, Avastin remains FDA approved for use in combination with paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer in the United States.

Source: U.S. Food and Drug Administration, USA

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