02.25.08
Genentech received accelerated approval from the FDA for Avastin in combination with paclitaxel chemotherapy for the first-line treatment of patients with locally recurrent or metastatic breast cancer. The approval is based on Phase III study (E2100) results showing that patients with metastatic breast cancer receiving Avastin with paclitaxel compared to paclitaxel alone, doubled 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 life-threatening diseases based on initial positive clinical data. Genentech is expecting results from a third Phase III trial in first-line metastatic breast cancer in late 2008. Full approval will be based on the results of two Phase III trials: AVADO (Avastin plus docetaxel chemotherapy vs docetaxel alone), and RIBBON-1 in first-line metastatic breast cancer.
"Today’s decision represents a major milestone for patients and oncologists in the U.S.," said William M. Burns, chief executive officer, division Roche Pharmaceuticals. "The FDA has recognized that Avastin is a breakthrough drug which is now approved in Europe and the U.S. for the three cancers with the highest death toll — breast, lung and colorectal cancer."
Avastin, an anti-angiogenic agent, has been shown to deliver improved overall and/or progression-free survival in colorectal, lung, breast and, renal cell cancer patients.
Avastin was approved in advanced breast cancer under the FDA's accelerated approval program, which allows the FDA to approve products for life-threatening diseases based on initial positive clinical data. Genentech is expecting results from a third Phase III trial in first-line metastatic breast cancer in late 2008. Full approval will be based on the results of two Phase III trials: AVADO (Avastin plus docetaxel chemotherapy vs docetaxel alone), and RIBBON-1 in first-line metastatic breast cancer.
"Today’s decision represents a major milestone for patients and oncologists in the U.S.," said William M. Burns, chief executive officer, division Roche Pharmaceuticals. "The FDA has recognized that Avastin is a breakthrough drug which is now approved in Europe and the U.S. for the three cancers with the highest death toll — breast, lung and colorectal cancer."
Avastin, an anti-angiogenic agent, has been shown to deliver improved overall and/or progression-free survival in colorectal, lung, breast and, renal cell cancer patients.