A late-stage study of Avastin (bevacizumab), in combination with taxane, anthracycline-based or capecitabine chemotherapies for first-line treatment of metastatic HER2-negative breast cancer, met its primary endpoint of increasing progression-free survival.
According to the makers of the drug, Swiss drug major Roche and majority-owned US biotechnology giant Genentech, the safety profile of Avastin was consistent with previous experience and no new safety signals were observed. The data, including additional analyses, will be submitted for presentation at a future medical meeting.
"The findings of this study, together with the positive PFS results from the E2100 and AVADO Phase III trials, support Avastin's ability to delay cancer progression with common chemotherapies in metastatic HER2-negative breast cancer," said Genentech chief medical officer Hal Barron. "We look forward to discussing these data with the [Food and Drug Administration] and are committed to securing full US approval of Avastin based on all the data in advanced breast cancer. We plan to submit the data from RIBBON 1 and AVADO to the FDA by mid-2009," he added.
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