Tasigna (nilotinib) has been given priority review status by the FDA for the treatment of adults with newly diagnosed Philadelphia chromosomepositive chronic myeloid leukemia (CML) in chronic phase.
Priority review is granted to therapies deemed to offer major advances in treatment or that provide a treatment where there is no adequate therapy, shortening the standard review time from 10 to six months.
In the relevant trial, significantly fewer patients receiving nilotinib have disease progression after 12 years compared with those receiving imatinib (Gleevec), the standard of care. Nilotinib also showed a statistically significant improvement over imatinib in every other measure of efficacy in the trial, including major molecular and complete cytogenetic responses at 12 months.
A news release from the manufacturer, Novartis, notes that in addition to the US, regulatory submissions have been filed in the EU and Japan. All filings are based on data showing superior efficacy for nilotinib in the first head-to-head comparison of the drug against imatinib in newly diagnosed Ph+ CML patients. If approved for the first-line indication, Tasigna will be the first drug for newly diagnosed patients to become available since the approval of Gleevec in 2002.
The regulatory submissions are based on data 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 that compared the efficacy and safety of nilotinib versus imatinib in adult patients with newly diagnosed Ph+ CML in chronic phase, the largest global randomized comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients.