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Switzerland first country to approve Tasigna

Switzerland has become the first country to approve Novartis' chronic myeloid leukaemia drug Tasigna (nilotinib), for patients who are unable to take Glivec, the company's blockbuster CML treatment.

Switzerland has become the first country to approve Novartis' chronic myeloid leukaemia (CML) drug Tasigna (nilotinib), for patients who are unable to take Glivec, the company's blockbuster CML treatment.

The drug (known as Gleevec in the US) received approval following an accelerated review by the Swiss health authority Swissmedic based on phase II trial results, which found high response rates.

"While over 90% of patients on Glivec survive after five years, we focused on helping the small percentage of patients who developed resistance or intolerance to Glivec, which led to the discovery of Tasigna," said Dr Daniel Vasella, chairman and CEO of Novartis.

Novartis says regulatory decisions are expected in the US and Europe later in 2007, while a regulatory submission was completed in Japan during the second quarter of 2007. The US Food and Drug Administration requested a three month extension of its regulatory review period on July 16.

"No new studies have been required, but only additional time to review the additional data," Novartis said in a statement.

Analysts at the time said the delay would not change Novartis estimates significantly but did increase the risk profile of the company, so the Swiss approval will help counteract the US approval delay. 

Phase III studies are expected to launch this year involving Tasigna in CML patients responding sub-optimally to other therapies as well as newly-diagnosed CML patients. A registration study is already underway in patients with gastrointestinal stromal tumors (GIST), which can also be treated with Glivec in certain countries.

Tasigna was developed in 2002, one year after Glivec was developed.

Glivec generated sales of USD1.4bn in Q2FY07, an increase of 14 per cent over the same period last year. 

Chronic myeloid leukaemia is one of the four most common types of leukaemia, responsible for about 15 per cent of all leukaemia cases globally, and caused by an overproduction of immature white blood cells.

Phase II results

Swissmedic approved Tasigna based on an open-label phase II study which evaluated the safety and efficacy of Tasigna in Gilvec-resistant or intolerant patients with Ph+ CML in chronic and accelerated phase. Efficacy was measured by cytogenetic response, (reduction or elimination of the Ph+ chromosome), and haematological response (normalisation of white blood cell counts).

Among 132 patients with chronic phase disease, major cytogenetic response was observed in 55 patients (42 per cent) after a median of 7.7 months' treatment. Among 64 patients with accelerated phase disease, major cytogenetic response was observed after a median of five months' follow-up in 20 (31 per cent).

25th July 2007

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