ROCKVILLE, Maryland—FDA has given Genentech’s antiangiogenesis agent Avastin (bevacizumab) accelerated approval for use in combination with paclitaxel for the first-line treatment of metastatic HER2-negative breast cancer.
The accelerated approval is based on the phase III multicenter, randomized, controlled clinical trial E2100 that showed a doubling in progression-free survival for Avastin plus paclitaxel (11.3 months vs 5.8 months for paclitaxel alone) (HR 0.48, P < .0001).
The E2100 study did not, however, show a significant improvement in overall survival and did show increased toxicity with Avastin.
Based on these data, last December, FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 5-4 against recommending approval of Avastin in this setting (see ONI, January 2008, page 22).
Genentech has shared with FDA a summary of the results from a second positive phase III trial (AVADO), and is expecting results from a third phase III trial (RIBBON I) in the first-line metastatic breast cancer setting in late 2008.
A full review of both the AVADO and RIBBON I data will be required for the accelerated approval to be converted into regular approval, the company said.
AVADO meets primary endpoint
The AVADO (BO17708) study is evaluating Avastin at either 15 mg/kg or 7.5 mg/kg every 3 weeks, in combination with docetaxel (Taxotere) 100 mg/m2 every 3 weeks for up to nine cycles, compared with docetaxel/placebo, in 736 patients receiving first-line treatment for their locally recurrent or metastatic HER2-negative breast cancer.
Genentech recently announced that the study had met its primary endpoint (for both doses) of prolonged progression-free survival. Overall survival data are not yet available. No new safety signals related to Avastin were observed.
The full AVADO results are expected to be presented at the annual ASCO meeting May 30 through June 3, 2008.