FDA says no to Avastin for breast cancer
Basel – The FDA has withdrawn the accelerated approval for Roche's Avastin (bevacizumab) to treat metastasising breast cancer. The US regulatory authority had originally granted accelerated approval for Avastin's use in treating breast cancer in 2008 when the drug's manufacturer Genentech submitted a study showing that Avastin extended progression-free survival. However, subsequent studies failed to confirm the initial findings, and in December 2010, following a hearing, the FDA's Center for Drug Evaluation and Research (CDER) recommended withdrawal of the drug for treating breast cancer. Genentech appealed the decision, and another hearing was held in June, at which time CDER again recommended withdrawal. FDA Commissioner Margaret Hamburg encouraged Roche's biotech daugther Genentech Inc. to continue to study the drug in the indication to identify patients who may benefit. Genentech plans to start a Phase III trial in 2012 of Avastin plus paclitaxel in previously untreated metastatic breast cancer. The trial will evaluate a potential predictive biomarker and will measure progression-free survival. At a June FDA hearing, Genentech proposed to conduct a confirmatory trial that would evaluate co-primary endpoints of PFS in the overall population and in a subgroup expressing high levels of VEGF-A, Avastin's target. Genentech markets Avastin in the U.S. and Roche sells it elsewhere. The drug is approved in the U.S. for metastatic colorectal cancer (mCRC), non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) and glioblastoma multiforme (GBM). The approval of Avastin for treating breast cancer patients in Europe remains unaffected.