SwitzerlandSwitzerland

FDA says no to Avastin for breast cancer

22.11.2011

Basel – The FDA has withdrawn the accelerated approval for Roche's Avastin (bevacizumab) to treat metastasising breast cancer.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.

SwitzerlandSwitzerland

30.03.2012

Basel/Hinxton (UK) – Two European teams have created huge repositories of cancer genomics data that help predict drug response. Swiss Novartis and the Boston-based Broad Institute have combined data obtained from large-scale...

SwitzerlandSwitzerland

27.03.2012

London/Lausanne – The global private equity firm Celtic Therapeutic L.L.L.P. believes in the power of antibody-drug conjugates (ADCs). It is investing $50m in a new Switzerland-based company called ADC Therapeutics Sarl which...

SwitzerlandSwitzerland

26.03.2012

Basel/Vienna - Following promising results from a Phase III study, Roche has submitted a regulatory application to EMA for subcutaneous Herceptin (trastuzumab) to treat HER2-positive breast cancer. Roche said subcutaneous...

SwitzerlandSwitzerland

09.03.2012

After the US Food & Drug Administration forced Swiss generics giant Sandoz AG to update its production facilities in Quebec, there are now fears that supplies of some medicines could grow tight in Canada. The regulatory authority...

SwitzerlandSwitzerland

08.03.2012

The hepatitis C space has seen a string of large deals in the last weeks that include a US$11bn buyout of Pharmasset by Gilead. Now Novartis is also trying to get in the game with the purchase of a global exclusive licence from...

SwitzerlandSwitzerland

06.03.2012

Allschwil – Swiss Actelion Ltd. has strengthened its commercial offerings by securing rights in certain countries to Auxilium’s biotech drug Xiaflex for treating tissue buildup under the skin. The US pharma is to receive US$10m...

SwitzerlandSwitzerland

06.03.2012

Zug – Life Sciences specialist HBM partners has raised €90m in the first close of its HBM BioCapital II fund, which will invest in revenue-generating companies in the pharmaceuticals, medical device and diagnostics sectors....

SwitzerlandSwitzerland

05.03.2012

Stans – Mondobiotech, a drug discovery company in troubled waters, could soon be under Italian ownership: The Swiss biotech announced it has entered into exclusive negotiations with Milan-based provider of pharmaceutical and...

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