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Pharmaceuticals / Inspections and Audits

FDA Updates Tasigna Labeling to Reflect Leukemia Findings

Jan. 4, 2018

The FDA updated the labeling for Tasigna (nilotinib) to clarify that certain leukemia patients may end their treatment after a sustained response.

The Novartis drug, approved in 2007, is indicated for Philadelphia chromosome positive chronic myeloid leukemia patients. According to updated dosing recommendations, patients with early (chronic) phase CML who have used the drug for three or more years and whose leukemia has responded to treatment may be eligible to stop taking the drug.

Responses to treatment must meet certain criteria as detected by an FDA-approved test. The decision was based on two single-arm trials with a total of 216 patients.

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