Novartis: FDA approves label change for leukemia drug.
(CercleFinance.com) - Novartis says that the FDA has approved the inclusion of data in the Tasigna US product label, making it possible for some people with chronic myeloid leukemia to discontinue therapy.
The Food and Drug Administration approved the inclusion of treatment-free remission (TFR) clarification in the label to include data about attempting treatment discontinuation in adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in the chronic phase.
Clinical trials have demonstrated that almost half of the patients who discontinued Tasigna remained in TFR approximately two years after stopping treatment, Novartis says.
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