FDA Requests Updated E2100 Data for Avastin sBLA Review

October 1, 2006

Before it will consider Genentech's supplemental Biologics License Application (sBLA) for Avastin (bevacizumab) plus chemotherapy as first-line treatment of metastatic breast cancer

SOUTH SAN FRANCISCO, California—Before it will consider Genentech's supplemental Biologics License Application (sBLA) for Avastin (bevacizumab) plus chemotherapy as first-line treatment of metastatic breast cancer, FDA wants to see a substantial safety and efficacy update from the pivotal E2100 trial. E2100 randomized metastatic breast cancer patients to receive paclitaxel with or without Avastin every 2 weeks. The request includes an independent review of patient scans for progression-free survival.

The company said in a press release that it has received a Complete Response Letter from FDA, indicating that a new 6-month review period will begin once the additional information requested is submitted.