Genentech announced that the FDA has extended the review period for the supplemental Biologics License Applications (sBLAs) for Avastin (bevacizumab) for previously untreated (first-line) advanced HER2-negative breast cancer by an additional 90 days. The FDA is currently reviewing two sBLAs submitted in November 2009 for Avastin in combination with taxane-based, anthracycline-based and capecitabine chemotherapies based on the results of the AVADO and RIBBON1 studies. Data from AVADO and RIBBON1 were submitted as part of Genentech’s effort to convert the accelerated approval to a full approval. FDA action on the SBLAs is expected by December 17, 2010. At this time, Avastin remains under accelerated approval in combination with paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer.
Avastin is already approved for first- and second-line treatment of metastatic colorectal cancer (mCRC) in combination with intravenous 5-FU-based chemotherapy, first-line treatment of unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel, and metastatic renal cell carcinoma in combination with interferon alfa.
Today’s announcement does not impact Avastin’s availability for its approved uses for other cancer types in the U.S. or approved uses, including breast cancer, in other countries.
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