SwitzerlandSwitzerland

MabThera approved in Europe for first line maintenance treatment of follicular lymphoma

29.10.2010

Basel – Roche’s blood cancer drug Mabthera (Ritusimab) has been approved by the European Commission as first line maintenance treatment for patients with follicular lymphoma who have responded to initial induction therapy. Approximately 70,000 patients are diagnosed every year with this rare blood cancer. The approval of the anti-CD20 monoclonal antibody is based on results from the phase III PRIMA study on 1,217 patients which is also the basis for a BLA Roche field by March 2010 in the US market. After two year maintenance treatment in patients who responded to initial treatment with rituximab plus chemotherapy, 82% of previously untreated patients who received injections with the antibody
were in remission compared to 66% of patients who did not. In the Phase III study, eight cycles of MabThera plus either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), CVP (cyclophosphamide, vincristine, prednisone) or FCM (fludarabine, cyclophosphamide, mitoxantrone) chemotherapy was used as initial treatment. 1,018 out of 1,217 patients responded and were randomised to receive MabThera alone, given once every two months for two years, or observation alone. The safety profile was consistent with those previously reported in pivotal studies of MabThera alone or in combination with chemotherapy. Serious adverse events (Grade 3 or 4) were reported in 23% of patients who received MabThera maintenance compared to 16% who did not, including low white blood cell counts (4% vs. 1%) and infections (4% vs. 1%)

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...

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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...

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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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No liability assumed, Date: 01.08.2014


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