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Jakavi shows long-term survival benefit in myelofibrosis

Trial demonstrates Novartis’ blood cancer drug cut risk of death by half over three years

Novartis' recently-approved treatment for blood cancer myelofibrosis Jakavi has been shown to improve overall survival dramatically over three years, according to a new study.

The data from the COMFORT-II study of Jakavi (ruxolitinib) found that the drug cut the risk of death by 52 per cent compared to conventional therapy in patients with advanced myelofibrosis, whilst also achieving sustained reductions in spleen size.

The JAK1/ JAK2 inhibitor - licensed from Incyte Corp - is "the first drug to demonstrate an improvement in overall survival in patients with advanced myelofibrosis", said lead investigator Alessandro Vannucchi of the University of Florence, who presented the data at the European Hematology Association (EHA) annual meeting over the weekend.

"We are encouraged by these latest study results, which reinforce that the rapid, positive effects of Jakavi in improving patients' symptoms are sustained over the long-term," he added.

News of the sustained improvement on Jakavi (sold as Jakafi in the US) bode well for the product, which has been tipped as a potential $1bn-plus product by 2016 if its use can be expanded into earlier-stage myelofibrosis and other diseases such as polycythemia vera. First-quarter 2013 sales came in at $35m.

Analysts have suggested that a clear effect on survival (there was a trend towards an improvement in earlier analyses of COMFORT-II and sister trial COMFORT-I) will be the key to unlocking the product's sales potential.  Patients with myelofibrosis typically have a median overall survival of just 5.7 years.

Myelofibrosis has a small patient population of a few tens of thousands of patients worldwide, so Novartis has set a high price for the product of around $90,000 per year, which has led to issues with reimbursement. For example, the UK's cost-effectiveness watchdog NICE turned Jakavi down in final draft guidance issued in April 2013.

Meanwhile, Jakavi will have the market to itself for at least as a couple of years, as rival JAK inhibitors such as Sanofi's SAR302503 and Gilead Sciences' CYT387 are still in mid to late-stage clinical development.

Sanofi's candidate is already in phase III testing, while Gilead has said it intends to start a pivotal trial candidate for its drug, which will include a head-to-head comparison with Jakavi, before the end of the year.

17th June 2013

From: Research

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