Genentech says that it has filed Avastin again to US regulators for the treatment of breast cancer in combination with paclitaxel for patients who have not received chemotherapy.
Genentech has resubmitted a supplemental Biologics License Application to the US Food and Drug Administration for Avastin (bevacizumab) in combination with paclitaxel chemotherapy for patients who have not received chemotherapy for their locally recurrent or metastatic breast cancer, the company announced.
The resubmission is based on the pivotal Phase III trial E2100 and marks the beginning of a six-month review period by the FDA. Genentech noted that it received a complete response letter from the agency in September 2006 requesting additional information from the trial, including an independent, blinded review of patient scans for progression-free survival, 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 trial investigators and presented at the 2005 annual meeting of the American Society of Clinical Oncology. Genentech said that no new safety signals emerged outside of those known to be associated with Avastin.
The news comes as Genentech’s partner Roche received approval in the European Union for the first-line treatment of patients with advanced non-small cell lung cancer in combination with platinum-based chemotherapy.