FDA : First-Line Nilotinib for Priority Review

I was confused by the use of the word 'slates' in this context... but I worked out that it probably means 'includes - as in 'writes on the slate' -rather than in the usual UK English meaning of to slate = to rubbish.... so 'FDA slates' is a good thing ;o)

.. but I worked out that it probably means 'includes - as in 'writes on the slate' -rather than in the usual UK English meaning of to slate = to rubbish.... so 'FDA slates' is a good thing ;o)
Sandy

FDA Slates First-Line Nilotinib for Priority Review
Elsevier Global Medical News. 2010 Feb 22, JS MacNeil

The Food and Drug Administration is speeding up its review of nilotinib as a potential first-line treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia, Novartis Pharmaceuticals Division announced on Feb. 19.

The agency's granting of priority review status follows a randomized phase III trial in which nilotinib, marketed by Novartis as Tasigna, outshone the current standard therapy in every 12-month measure.

Compared with imatinib (Gleevec), nilotinib produced faster, deeper remissions with fewer patients progressing at 1 year in the ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients) trial. Results were presented at the American Society of Hematology annual meeting in December 2009.

Priority review moves the timeline for FDA consideration from 10 months to 6 months, according to East Hanover, N.J.-based Novartis. Nilotinib is approved to treat chronic phase and accelerated phase CML that is Philadelphia chromosome positive in adult patients who are resistant to or cannot tolerate imatinib.

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FDA : First-Line Nilotinib for Priority Review