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Novartis announced today 18-month results (median follow-up) showing that Tasigna (nilotinib) significantly surpasses Glivec (imatinib)* in slowing disease progression in adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
This 18-month median follow-up is from the first head-to-head comparison of these two oral therapies as initial treatment for this life-threatening blood cancer and will be presented on June 7 at the 46th American Society of Clinical Oncology (ASCO) annual meeting in Chicago.
Tasigna produced deeper levels of molecular response than Glivec in front-line Ph+ CML and significantly reduced progression to accelerated phase and blast crisis, resulting in fewer deaths due to CML. Notably, three times more patients achieved undetectable disease at the molecular level with Tasigna than with Glivec. Further, Tasigna surpassed Glivec in other key measures of treatment efficacy.
“Tasigna demonstrates that by more selectively inhibiting BCR-ABL, the key driver of Ph+ CML, we can reduce progression to advanced disease even further than with the current gold standard Glivec,” said Richard Larson, MD, ENESTnd study investigator and Director of the Hematologic Malignancies Program at the University of Chicago. “The efficacy and safety findings achieved by Tasigna in this study provide patients and physicians with an important new treatment option.”
In February 2010 the US Food & Drug Administration (FDA) granted Tasigna priority review status for newly diagnosed Ph+ CML patients. Regulatory submissions have been filed in the EU, Switzerland and Japan. The new ENESTnd data to be presented at ASCO will further confirm the findings in those filings, all of which were based on 13.8-month median follow-up data from the study.
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