Genentech Announces Resubmission of Supplemental Biologics License Application for Avastin in Combination with Paclitaxel
Genentech, Inc. announced that the company resubmitted a supplemental biologics License Application (sBLA) to the U.S. food and Drug Administration (FDA) for Avastin® (bevacizumab), in combination with paclitaxel chemotherapy, for patients who have not received chemotherapy for their locally recurrent or metastatic breast cancer. The resubmission, based on the pivotal Phase III trial E2100, 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 (ASCO). No new safety signals emerged outside of those known to be associated with Avastin.
"We would like to thank ECOG investigators for their work on this study, which showed Avastin provided a significant clinical benefit for advanced breast cancer patients in the trial," said Hal Barron, M.D., senior vice president, Development and chief medical officer. "The data from the blinded independent analysis support the original interim results presented by ECOG investigators. We look forward to our continued collaboration with the FDA and ECOG on this resubmission, as it represents an important milestone in our effort to develop novel therapies for breast cancer patients."
Avastin is being studied worldwide in more than 300 clinical trials and in more than 20 different tumor types, including for its potential use in adjuvant (therapy given after surgery to help decrease the risk of cancer recurrence) and metastatic colorectal, renal cell (kidney), breast, pancreatic, non-small cell lung, prostate and ovarian cancers.
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