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Home Industry News Novartis reports first global approval of Tasigna

Novartis reports first global approval of Tasigna

30th July 2007

With decisions from regulators in Europe and the US expected later this year, Novartis has announced the first global approval of Tasigna (nilotinib) as a treatment for chronic myeloid leukaemia patients who have shown resistance or intolerance to its earlier drug Glivec (imatinib).

The compound has been approved in Switzerland following an accelerated review of the drug by local health authorities based on positive results from a key phase II clinical trial showing a high response rate for the compound which was also generally well-tolerated by patients.

In this trial, 42 per cent of patients with chronic phase disease showed a major cytogenetic response after a median of 7.7 month’s treatment, while 31 per cent of patients with accelerated phase disease showed a similar response after a median of five-months follow-up.

Dr Daniel Vasella, chairman and chief executive officer of Novartis, said: “While over 90 per cent 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.”

He added that the firm was pleased with the rapid time from synthesis of the compound to its successful marketing, with less than five years having elapsed since the discovery of the drug.

In December 2006, Novartis published phase II clinical trial results showing that 51 per cent of Glivec-resistant patients achieved a significant reduction in blood cells with the defective Philadelphia chromosome.

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