Genentech confirms EMA, FDA updates on Avastin for metastatic breast cancer

GenentechDec 17 2010

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), confirmed that following the reviews of Avastin^® (bevacizumab) in metastatic breast cancer by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), the following regulatory announcements were made by the individual health authorities:

“the benefits of this combination outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer”

EMA/European Committee for Medicinal Products for Human Use (CHMP) update:

• The EMA has confirmed that Avastin in combination with paclitaxel has been convincingly shown to enable women with metastatic breast cancer to live longer without their disease getting worse (progression-free survival).
• The EMA has also stated that "the benefits of this combination outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer".
• Paclitaxel is the chemotherapy most frequently used in Europe and also most frequently partnered with Avastin for the first-line treatment of metastatic breast cancer.
• The CHMP, which is part of EMA, recommended the removal of the combination of Avastin with docetaxel from the label based on uncertainty about the benefit of the combination and also recommended against a label extension with capecitabine.
• A European Commission decision on this opinion will be issued in due course.
• The CHMP opinion does not affect the other approved uses of Avastin in the European Union for advanced colorectal, kidney and lung cancer.

U.S. FDA update:

• The FDA notified Genentech of its "Proposal to Withdraw Marketing Approval" of Avastin for first-line treatment of metastatic HER2 negative breast cancer in combination with paclitaxel and issued a "Notice of Opportunity for a Hearing" (NOOH). An NOOH is the mechanism FDA uses to provide a company an opportunity for a hearing on a proposal to withdraw an indication.
• Genentech will request a hearing. If FDA grants a hearing, there is no set date for when this would occur.
• Until the conclusion of these proceedings, Avastin remains FDA-approved for use in combination with paclitaxel for the first-line treatment of metastatic HER2-negative breast cancer.
• The FDA also issued Complete Responses on AVADO and RIBBON1 for the first-line use of Avastin in combination with other chemotherapies in metastatic breast cancer and a Complete Response on RIBBON2 for the second-line use of Avastin plus chemotherapy in metastatic breast cancer.
• The FDA's decision does not impact Avastin's availability for its approved uses for other cancer types in the United States.

"We are pleased that the EMA has confirmed the benefits of Avastin with paclitaxel and that Avastin will continue to be available for women with metastatic breast cancer living within the European Union with metastatic breast cancer," said Hal Barron M.D., chief medical officer and head, Global Product Development. "We believe women living in the United States with metastatic HER2-negative breast cancer should also have Avastin as a treatment option, and, therefore, we will request a hearing with the FDA."

Information for Patients and Physicians in the United States

Until the conclusion of the proceedings with FDA, Avastin remains approved for use in combination with paclitaxel for the first-line treatment of metastatic HER2-negative breast cancer in the United States. The effectiveness of Avastin in metastatic HER2-negative breast cancer is based on an improvement in progression-free survival in the E2100 study. There are no data available showing that Avastin improves disease-related symptoms or survival in metastatic HER2-negative breast cancer. Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease.

Doctors with questions about the use of Avastin for metastatic breast cancer can call Genentech's Medical Communications group at (800) 821-8590 or their Genentech Medical Science Liaison. Patients with questions or concerns about insurance coverage can call Genentech's Access Solutions Group at (866) 4 ACCESS.