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"TOPS reaffirms Gleevec as the standard of care for newly diagnosed CML patients," said Jorge Cortes, MD, Professor of Medicine and Deputy Chair of Leukemia at the University of Texas MD Anderson Cancer Center in Houston. "We see a strong trend for rapid response with the 800 mg dose. As with trials like IRIS, further follow up will be needed to assess what this rapid early response will mean in terms of long-term benefit."
TOPS also showed that patients with lower blood levels of Gleevec at one month had a lower molecular response at a year, an observation made in previous studies(2). Cumulatively, these data suggest that maintaining adequate blood levels may help attain better clinical responses(2).
These findings, from the first analysis of the TOPS data set, will be presented on Saturday, June 14, at the 2008 Congress of the European Hematology Association (EHA) in Copenhagen.
"Our robust clinical program with Gleevec continues to provide meaningful insights into the treatment of Ph+ CML and other types of cancer," said Diane Young, MD, Head of Global Medical Affairs at Novartis Oncology. "Novartis continues to invest in trials like ENESTnd, which is comparing Tasigna to Gleevec in the first-line setting, to build on this knowledge and further enhance treatment outcomes for patients."
ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of
newly diagnosed Ph+ CML patients) is designed to study the efficacy and
safety of Tasigna(R) (nilotinib) capsules vs. Gleevec in newly diagnosed
patients in the chronic phase. ENESTnd is currently underway and will
enroll approximately 771 patients at 220 centers worldwide. Tasigna is
currently approved for the treatment of Ph+ CML in the chronic or
accelerated phase in patients resistant to, or intolerant of, Gleevec.
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