SwitzerlandSwitzerland

FDA greenlights Novartis’ Tasigna for newly diagnosed CML

21.06.2010

Basel – The US Food and Drug Administration (FDA) has approved Tasigna (nilotinib) 150 mg pills for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. A study is ongoing and further data will be required to determine long-term outcome. The US approval was based on results of the ENESTnd Phase III clinical trial, published in The New England Journal of Medicine (NEJM). In the head-to-head trial against Gleevec, Tasigna demonstrated improved treatment efficacy, as has been previously reported. The Bcr-Abl inhibitor reduced both the level of Philadelphia chromosome (cytogenetic response) as well as the anount of the Bcr-Abl protein (molecular response) faster than Gleevec, resulting in lower rates of cancer progression even as early as 12 months, with the drug well tolerated by patients. Reduction of Bcr-Abl is considered to be a critical therapeutic milestone associated with good long-term outcomes for patients with Ph+ CML. Fewer patients discontinued due to adverse events from the Tasigna 300 mg twice daily arm of the study compared to the Gleevec 400 mg once daily arm and no patients in the study had a prolongation of the QT interval >500 milliseconds. In addition, no sudden deaths occurred with either treatment. Tasigna can cause a possible life-threatening heart problem called QTc prolongation, which causes an irregular heartbeat, which may lead to sudden death. Regulatory submissions for Tasigna in the first-line indication are under way worldwide, with applications currently filed in the EU, Switzerland and Japan. At the beginning of June, Novartis’ competitor BristolMyers Squibb also reported positive results with its BCR-ABL kinase inhibitor dasatinib (Sprycel) in a head-to-head trial with Gleevec.

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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