Novartis leukaemia drug shows ‘impressive’ response

Novartis has this week published new clinical data showing that patients with a form of leukaemia that had exhibited resistance or intolerance to Glivec (imatinib) showed an elimination or significant reduction in blood cells with a defective chromosome following treatment with Tasigna (nilotinib).

The phase II trial showed that 51 per cent of Glivec resistant patients showed at least a significant reduction in blood cells with this chromosome, with 74 per cent of these patients achieving a normalised white blood cell count. Similar results were achieved in 55 per cent of patients intolerant to Glivec.

Tasigna was first synthesised in August 2002 and entered phase I clinical trials in 2004.

David Epstein, chief executive officer and president of Novartis Oncology, said; “These exciting data demonstrate that Tasigna has the potential to offer a compelling new treatment option for patients with PH+ CML [Philadelphia chromosome-positive chronic myeloid leukaemia]”.

He added that the company would be further investigating the possible benefits of the compound through phase III trials in earlier cases of CML.

Last week, the New England Journal of Medicine published data showing that Novartis drug Glivec was a “durable and well-tolerated long-term therapy” for adult patients with newly-diagnosed Ph+ CML.