FDA grants accelerated approval of Avastin in combination with paclitaxel chemotherapy for first-line treatment of patients with advanced HER2-negative breast cancer

Avastin now approved for the three cancers with the highest death toll in Europe and the US

Roche today announced that Genentech has received U.S. Food and Drug Administration (FDA) accelerated approval for Avastin (bevacizumab), in combination with paclitaxel chemotherapy, for the first-line treatment of patients with locally recurrent or metastatic breast cancer. The approval is based on a phase III study (E2100) which showed that for patients with metastatic breast cancer the addition of Avastin to paclitaxel compared to paclitaxel alone doubled the chance of being alive without the disease advancing (“progression-free survival”). In Europe Avastin received full approval for the treatment of metastatic breast cancer in March 2007.

Avastin was approved in advanced breast cancer under the FDA’s accelerated approval program, which allows the FDA to approve products for cancer or other life-threatening diseases based on initial positive clinical data. Genentech has shared with the FDA a summary of the results from a second positive phase III trial (AVADO = Avastin plus docetaxel chemotherapy vs docetaxel alone), and is expecting results from a third phase III trial (RIBBON-1) in first-line metastatic breast cancer in late 2008. A full review of both the AVADO and RIBBON-1 data by the FDA will be required for the accelerated approval to be converted into a full approval. As a part of Genentech’s commitment to fully evaluate Avastin in breast cancer, they will also submit data to the FDA from three additional randomized trials that are either ongoing or planned.
“This is excellent news representing a significant advancement in breast cancer therapy.” said Dr David Miles, medical oncologist, Mount Vernon Hospital, UK. “The decision confirms the importance of progression-free survival as a clinically meaningful benefit to patients. Avastin effectively doubles the time patients live without their disease advancing which is highly significant for our patients and their families.”

Globally, breast cancer is the second most common form of cancer and the second leading cancer killer of women with an estimated annual death toll in excess of 400,000.1

“Today’s decision represents a major milestone for patients and oncologists in the US” said William M. Burns, CEO Division Roche Pharmaceuticals. “The FDA has recognized that Avastin is a breakthrough drug which is now approved in Europe and the US for the three cancers with the highest death toll – breast, lung and colorectal cancer.”

Avastin is the first anti-angiogenic agent which has been shown to consistently deliver improved overall and/or progression-free survival benefit for colorectal, lung, breast and, renal cell cancer patients.
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