The National Institute of Health and Clinical Excellence (NICE) - the United Kingdom equivalent of the USA's National Institutes of Health - has recommended that Tasigna be used exclusively to treat Philadelphia chromosome-positive CML in patients who are resistant to or can't tolerate Gleevec (imatinib).
"Ask your doctor if or when it's time to switch medications."
In making this final guidance, NICE also evaluated the use of Sprycel (dasatinib) and high-dose Gleevec.
This recommendation confirms earlier guidance published in August, 2011.
CML is among the most common types of leukemia in the UK. According to NICE, about 20 percent of patients are forced to stop taking one of the first-line therapies because of resistance to the drugs, or because side effects become intolerable.
The NICE guidance published January 17, 2012 was based on data from two clinical trials involving CML patients who could no longer take Gleevec.
In the 24-month Phase II study, researchers found:
- 44% of patients treated with twice daily 400mg Tasigna achieved complete cytogenic response (CCyR), meaning that the Philadelphia Chromosome that causes CML had disappeared.
- 84% maintained CCyR.
- 87% achieved overall survival.
Follow-up data from a longer, 48-month study showed that 78 percent of patients were still alive. These findings were presented at the 2011 American Society of Hematology Society meeting.
“At Novartis, our priority is to ensure that as many patients as possible can benefit from innovative therapies, like nilotinib, which we have developed to address unmet needs in difficult-to-treat diseases,” said Panos Alexakos, oncology general manager, Novartis UK & Ireland.