Tasigna Approved for CML

Following a priority review, Novartis received FDA approval for Tasigna 150 mg capsules for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Following a priority review, Novartis received FDA approval for Tasigna 150 mg capsules for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML). With this approval, Tasigna becomes the first new treatment option for newly diagnosed patients since the introduction of Gleevec tablets. The approval was based on results from a Phase III trial evaluating the efficacy and safety of Tasigna in newly diagnosed Ph+ CML patients. The ...

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