June 18, 2010
Tasigna approved for the treatment of newly diagnosed chronic myeloid leukemiaNovartis 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.
For more information call (800) 693-9993 or visit www.tasigna.com.