Novartis announced that Tasigna (nilotinib) 150 mg capsules have been approved by the FDA for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. This approval is based on results of the randomized, open-label, multicenter ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients) Phase 3 clinical trial.  In this head-to-head trial against Gleevec (imatinib), Tasigna demonstrated improved treatment efficacy, as has been previously reported. Tasigna reduced Bcr-Abl faster than Gleevec, resulting in lower rates of cancer progression even as early as 12 months.   

Tasigna is a potent and selective inhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+ CML. Tasigna is a kinase inhibitor already approved for chronic and accelerated phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in adults resistant or intolerant to imatinib.

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