Genentech’s Avastin gets review panel
Executive Summary
FDA's Oncologic Drugs Advisory Committee will review Avastin (bevacizumab) in combination with paclitaxel chemotherapy for patients who have not received chemotherapy for locally recurrent or metastatic breast cancer, Genentech announces Sept. 13. ODAC is scheduled to meet Dec. 4-5. Genentech resubmitted the sBLA in August, setting up a February 23, 2008 action date (1"The Pink Sheet" Aug. 27, 2007, In Brief). The resubmission followed a "complete response" letter issued by the agency in September 2006 that requested an independent review of patient scans for progression-free survival...
FDA's Oncologic Drugs Advisory Committee will review Avastin (bevacizumab) in combination with paclitaxel chemotherapy for patients who have not received chemotherapy for locally recurrent or metastatic breast cancer, Genentech announces Sept. 13. ODAC is scheduled to meet Dec. 4-5. Genentech resubmitted the sBLA in August, setting up a February 23, 2008 action date (1 'The Pink Sheet' Aug. 27, 2007, In Brief). The resubmission followed a "complete response" letter issued by the agency in September 2006 that requested an independent review of patient scans for progression-free survival.... |