In 2010, 3 new studies, with different chemotherapies in combination with Avastin, were submitted to FDA, all failing to show benefit on OS and showing smaller PFS benefit than before and more toxicities, some serious.
In July 2010, ODAC voted 12:1 to recommend withdrawal of the conditional approval as the risks outweigh the benefits in this indication and in December 2010, the FDA withdrew the approval of Avastin fo the treatment of metastatic breast cancer. (It remains approved by FDA for advanced colon, lung, kidney and brain cancers.) EMA affirmed the approval of Avastin with paclitaxel for the same indication, as the basis for that approval hadn’t changed.
In July 2010, ODAC voted 12:1 to recommend withdrawal of the conditional approval as the risks outweigh the benefits in this indication and in December 2010, the FDA withdrew the approval of Avastin fo the treatment of metastatic breast cancer. (It remains approved by FDA for advanced colon, lung, kidney and brain cancers.) EMA affirmed the approval of Avastin with paclitaxel for the same indication, as the basis for that approval hadn’t changed.