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US FDA OKs label update for Novartis' Tasigna with treatment-free remission data

The U.S. Food and Drug Administration approved the inclusion of treatment-free remission data to the product label for Novartis AG's blood cancer drug Tasigna.

Tasigna is now the first and only BCR-ABL tyrosine kinase inhibitor to include data in its prescribing information about attempting treatment discontinuation in eligible adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase after achieving sustained deep molecular response of MR4.5.

This approval follows a priority review for a supplemental new drug application for Tasigna seeking the addition of the information and is based on safety and efficacy results from analyses of two open label trials where patients achieved a sustained MR4.5 with Tasigna in both the first-line setting or after switching from Glivec.