Novartis Pharmaceuticals has this week launched its new treatment for chronic myeloid leukaemia in the UK as a follow-up to its blockbuster offering Glivec (imatinib). Tasigna (nilotinib) has been designed to target cell lines resistant to Glivec and is available to treat patients who are intolerant or resistant to previous therapies.

In clinical trials, Tasigna was effective in 77% of patients in the early stage of CML who were resistant or intolerant to other therapies – meaning blood cell counts returned to normal. In addition, 40% of patients achieved a complete cytological response with no abnormal chromosomes – the root cause of CML – detected in the bone marrow cells. At 12 months, the overall survival rate was 95%.

Tasigna targets the tyrosine kinase enzyme responsible for the reproduction of CML cells, but does so more specifically than Glivec and on fewer pathways than other TK inhibitors, thereby reducing the likelihood of side effects. Although it is currently approved for second-line use, Novartis is also exploring its use in the first-line setting as it may ultimately be a better molecule for newly-diagnosed patients.

Tasigna is an oral pill taken twice-daily and was first approved in Switzerland in July last year, followed by a green light in the USA and across Europe in the November. It is one of a number of medicines Novartis hopes will return it to dynamic growth in the second half of 2008.

Around 3% of Glivec patients are thought to be eligible for Tasigna therapy whereas, previously, few treatment options were available for these individuals. For patients who develop resistance to Glivec, there is the opportunity to move to a higher dose, failing that Bristol-Myers Squibb’s competing agent Sprycel (dasatinib) or, now, Novartis’ Tasigna.

A spokesperson for Novartis Pharmaceuticals told PharmaTimes UK News that Tasigna is more expensive than Glivec because of the second-line indication, but priced exactly the same as dasatinib to the National Health Service (£2432.85 for 28 days’ supply).

Tasigna is also on the so-called ‘horizon scanning’ for the UK’s cost effectiveness watchdog, the National Institute for Health and Clinical Excellence, which recommends where NHS money should be spent. Novartis is anticipating being asked for a submission by the end of the year but in the meantime is hoping for a thumbs up from Scotland’s equivalent, the Scottish Medicines Consortium, on June 9 when the decision is being made public.