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FDA Requests Updated E2100 Data for Avastin sBLA Review

FDA Requests Updated E2100 Data for Avastin sBLA Review

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.

 
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