Genentech’s information submitted to the FDA during the review of the sBLAs for Avastin for previously untreated (first-line) advanced HER2-negative breast cancer has been deemed a major amendment.
Genentech is expecting FDA action on the sBLAs by 17 December 2010.
Genentech stated that Avastin remains under accelerated approval, which was granted by the FDA in February 2008 for the drug in combination with paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer.
Genentech has submitted two sBLAs 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 which are currently being reviewed by the FDA.
Genentech Product Development executive vice president and chief medical officer Hal Barron said that they were pleased by the FDA’s decision to review additional information on Avastin and are committed to working closely with the agency during this extended review period.