More Support for Avastin in Advanced Breast Cancer

As part of the provisional FDA approval of Avastin (bevacizumab) in metastatic breast cancer, Genentech and Roche continue to supply more data supporting use of the anti-angiogenesis mAb.

In an international, 2-part, placebo-controlled, phase 3 study of 1237 women with advanced HER2-negative breast cancer, the addition of Avastin to either taxane or anthracycline-based chemotherapy (group 1) or capecitabine (group 2) significantly prolonged the primary endpoint of progression-free survival (PFS).* These data complement findings from the E2100 and AVADO phase 3 trials of Avastin in advanced HER2-negative breast cancer.

Currently Avastin is FDA approved for use, in combination with paclitaxel, in chemotherapy-naive patients with advanced HER2-negative breast cancer. The company emphasizes that Avastin has not been shown, as yet, to increase survival or improve disease-related symptoms in breast cancer.

Genentech's chief medical officer, Hal Barron, says that the data from this latest trial, RIBBON-1, and findings from AVADO will be submitted to the FDA by the middle of next year. Data from 3 ongoing or planned trials will be provided to the FDA as well.

Avastin is also FDA approved for the first- or second-line treatment of metastatic colorectal cancer, in combination with IV 5-FU-based chemotherapy, and for the first-line treatment of unresectable, locally advanced, recurrent or metastatic nonsquamous NSCLC, in combination with carboplatin and paclitaxel.

5-FU = 5-fluorouracil; HER2 = human epidermal growth factor receptor 2; mAb = monoclonal antibody; NSCLC = non-small cell lung cancer.

* Time from randomization to disease progression or death.