FDA approves Tasigna for chronic myeloid leukemia


The US Food and Drug Administration has approved 150 mg Tasigna (nilotinib) capsules as a first-line therapy for patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (CML). Tasigna is the first drug to be given approval for CML since the FDA approved Gleevec almost a decade ago.

Approval comes thanks to results from the ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients) Phase III clinical trial, a randomized, open-label, multicenter trial pitting Tasigna's safety and efficacy profile against that of Gleevec. The data has been published in the New England Journal of Medicine.

Pharmaceutical giant Novartis is the maker of both Gleevec and Tasigna. The company will likely be losing patent protection on Gleevec sometime in 2010 in the US.

By Ross Bonander

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