Genentech Resubmits Application for Avastin in Combination With Paclitaxel

Genentech reported that it has resubmitted a supplemental biologics license application to the FDA for Avastin in combination with paclitaxel chemotherapy, for patients who have not received chemotherapy for their locally recurrent or metastatic breast cancer.

According to Genentech, the resubmission for Avastin (bevacizumab) is based on data from the pivotal Phase III trial E2100 and marks the beginning of a six-month review period by the FDA.

In September 2006, the company received a complete response letter from the FDA requesting additional information from the trial, including an independent, blinded review of patient scans for progression-free survival.

The company reported that results of the independent review are consistent with the magnitude of benefit initially assessed by Eastern Cooperative Oncology Group trial investigators. No new safety signals emerged outside of those known to be associated with Avastin, the company added.