FDA reviewing first-line Avastin/paclitaxel for advanced breast cancer

SOUTH SAN FRANCISCO, California-Genentech has resubmitted a supplemental biologics license application to FDA for Avastin (bevacizumab) in combination with paclitaxel as first-line therapy for locally recurrent or metastatic breast cancer. The resubmission, based on the pivotal phase III E2100 trial, marks the beginning of a 6-month FDA review period. FDA has scheduled an advisory panel review of the application in December. The agency had requested additional information from the trial, including an independent, blinded review of patient scans for progression-free survival, the primary endpoint. Genentech said that "the data from the independent analysis support the original interim results."