During a U.S. Food and Drug Administration (FDA) hearing on Wednesday, the FDA?s Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA withdraw its approval of bevacizumab (Avastin?, Roche/Genentech) 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 bevacizumab plus paclitaxel is still FDA approved for women with HER2-negative metastatic breast cancer. The FDA Commissioner will make the final decision on whether bevacizumab should remain approved for metastatic breast cancer. The FDA has not announced when the Commissioner will make the final decision. Until the FDA Commissioner makes the final decision, bevacizumab remains FDA approved for use in combination with paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer in the United States.

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

?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.?

Freedom of Access to Medicines
On Wednesday, breast cancer patients and their families expressed extreme disappointment decision to recommend the removal of bevacizumab from the approved medication list for treatment of late stage breast cancer.

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Not unexpected
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 bevacizumab, criticized the FDA panel’s makeup as lacking expertise in the area of breast cancer.

Not impartial
“This 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. But we had breast cancer oncologists testifying on our behalf yesterday to keep patient access to Avastin,” Kalley said. “Additionally, this panel was handpicked by FDA Director of the Office of Oncology Products, despite rules that the panel must be independent of him. Nothing in this panel’s process seems impartial or fair.”

Kalley pointed out that the FDA dismissed anecdotal evidence when listening to super-responding patients give their stories of survival, but then later used anecdotal evidence to help make its case against using Avastin for breast cancer patients. He asked FDA Commissioner Margaret Hamburg, who will make the final decision on bevacizumab, to continue allowing breast cancer patient use of the medication.

“We appeal to FDA Commissioner Margaret Hamburg to correct this grave injustice and do the right thing by extending the label for Avastin to provide continued coverage for metastatic breast cancer,” Kalley said.

Effectiveness of bevacizumab
The effectiveness of bevacizumab in HER2-negative metastatic breast cancer is based on an improvement in progression-free survival (PFS) in the E2100 study. There are no data available showing that Avastin improves disease-related symptoms or survival in HER2-negative metastatic breast cancer.

European status
In Europe, bevacizumab is licensed in combination with paclitaxel chemotherapy and, as from yesterday, in combination with capecitabine (Xeloda?, Roche/Genentech) for women with metastatic breast cancer in the first-line setting. The European Commission?s latest decision to extend the Avastin label provides an additional first-line treatment option for women in whom treatment with other chemotherapies, including taxanes or anthracyclines, is not considered appropriate.

For more information:
Bevacizumab Receives Broader EU label for Treatment of Women with Metastatic Breast Cancer.

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