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Gleevec(R) (imatinib mesylate) tablets* is the standard treatment for Ph+ CML and rapidly transformed the treatment of CML when it was introduced in 2001. An ongoing Phase III trial called ENESTnd (Evaluating Nilotinib Efficacy in Clinical Trials of Newly Diagnosed Ph+ CML Patients) is evaluating Tasigna vs. Gleevec in newly diagnosed patients and is now fully accrued. Data from ENESTnd will be reported once available.

"Building on the wealth of scientific and clinical knowledge we have gained with Gleevec, Novartis strives to continually uncover novel approaches to help Ph+ CML patients achieve the best long-term outcomes," said David Epstein, President and CEO, Novartis Oncology.

Tasigna is a tyrosine kinase inhibitor approved for the treatment of adult Ph+ CML patients in the chronic or accelerated phases who are resistant or intolerant to prior treatment including Gleevec. Tasigna was specifically designed to inhibit Bcr-Abl, the key cause and driver of Ph+ CML and its mutations. The Philadelphia chromosome is found in nearly all patients with CML.

Study results

The first study, conducted by the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA), is an ongoing, open-label, single-stage, multicenter Phase II clinical trial, designed to evaluate the therapeutic efficacy and safety of Tasigna 800 mg/day as a first-line treatment. Seventy-three patients with newly diagnosed Ph+ CML in early chronic phase are enrolled in the trial. After six months of treatment, 96% of patients had achieved CCyR(2).

In addition, 74% of patients achieved MMR, defined as Bcr-Abl/Abl ratio < 0.1%. The percentage of patients achieving this level of response rapidly increased after one month of treatment. Adverse reactions were manageable with dose adaptations. The incidence of an
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