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news.Genentech 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.
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The resubmission, based on a pivotal phase III trial, 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 (PFS), the primary endpoint of the trial.
The results of the independent review are consistent with the magnitude of benefit initially assessed by Eastern Cooperative Oncology Group (ECOG) trial investigators and presented at the 2005 annual meeting of the American Society of Clinical Oncology. No new safety signals emerged outside of those known to be associated with Avastin.