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Two Novartis Phase III Studies Show Twice as Many Ph+ CML Patients Achieve Deeper Levels of Response With Tasigna® Compared to Gleevec®
Date:12/12/2011

n the Gleevec arm, the most commonly reported AEs were diarrhea (43.6%), nausea (39.6%) and vomiting (25.0%)(2).

There were two new cases of QTc prolongation increases greater than 60 msec from baseline observed since the last data cut-off, one each in the Gleevec arm and the Tasigna 400 mg arm (total of 1, 1, and 3 patients in Gleevec, Tasigna 300 mg and Tasigna 400 mg arms, respectively). With the 36-month data cut-off, no patient in any treatment arm had a QTc prolongation greater than 500 msec(2).

*Known as Glivec® (imatinib) outside the US, Canada and Israel.

About TasignaTASIGNA® (nilotinib) is approved for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The effectiveness of TASIGNA for this indication is based on major molecular response and cytogenetic response rates at 12 months. The study is ongoing and further data will be required to determine long-term outcome.

TASIGNA is also approved in more than 90 countries for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant or intolerant to at least one prior therapy, including Gleevec. The effectiveness of TASIGNA for this indication is based on hematologic and cytogenetic response rates.

BOXED WARNING and Important Safety Information for TASIGNA (nilotinib): 

WARNING: QT PROLONGATION AND SUDDEN DEATHS 

TASIGNA prolongs the QT interval. Prior to TASIGNA administration and periodically, monitor for hypokalemia or hypomagnesemia and
correct deficiencies. Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and follow any
dose adjustments.  

Sudden deaths have been reported in patients receiving nilotinib. Do not administer TASIGNA to patients with hypokalemia,
hypomagnesemia, or long QT syndrome.  

Avoid
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SOURCE Novartis
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