February 19, 2010
FDA grants priority review to Tasigna for newly diagnosed chronic myeloid leukemiaNovartis announced that Tasigna (nilotinib) 200 mg capsules has been granted priority review by the FDA for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. FDA priority review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. This status accelerates the standard review time from 10 to six months. Tasigna demonstrated that significantly fewer patients progressed to more advanced stages of the disease than the standard of care Gleevec (imatinib mesylate) tablets at 12 months. Tasigna also showed a statistically significant improvement over Gleevec in every other measure of efficacy in the trial, including major molecular response (MMR) and complete cytogenetic response (CCyR) at 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.
For more information call (800) 693-9993 or visit www.tasigna.com.