SwitzerlandSwitzerland

First personalised drug Zelboraf is approved in EU

21.02.2012

Basel/Berkeley – Europe enters into the age of personalised medicine. The European Commission has approved the melanoma drug Zelboraf. While the compound was developed by US-based Plexxikon Inc., owned by Daiichi Sankyo Group, the companion diagnostic is made by Roche. Zelboraf is a selective oral blocker of the oncogenic V600E mutant BRAF kinase RO5185426 in patients with metastatic melanoma. About half of patients carry the mutation. “We are very pleased that our strategy to co-develop Zelboraf along with a companion diagnostic helped accelerate the availability of this personalised medicine for these patients”, said Plexxikon'S CEO Peter Hirth. Roche claims that the companion diagnostic significantly reduced development and approval time of the treatment. The cobas 4800 BRAF V600 test is already commercially available in Europe. Roche Molecular Diagnostics developed the test following a 2005 agreement with Plexxikon. It is the first companion diagnostic designed simultaneously with the drug from scratch. The package has already been approved in the US, Switzerland, Israel, Brazil, New Zealand and Canada. In contrast to existing treatments with interleukin 2 or the chemotherapeutic agent dacarbazine, to which 10-20% of melanoma patients respond, targeted treatment with Zelboraf showed a response rate in more than 80% of patients. After a year of treatment, 55% of patients who received Zelboraf were alive, according to results from the Phase III study, as compared to 43% of patients who received chemotherapy.

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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