FDA extends label of Tasigna to include treatment free remission data for patients with Philadelphia chromosome-positive CML in the chronic phase. - Movartis

Novartis announced that the FDA approved the inclusion of Treatment-free Remission (TFR) data in the Tasigna (nilotinib) US product label. Tasigna is now the first and only BCR-ABL tyrosine kinase inhibitor (TKI) to include data about attempting treatment discontinuation in eligible adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) after achieving sustained deep molecular response of MR4.5 (BCR-ABL1 International Scale [IS] <= 0.0032 in its fda-approved prescribing information.>

TFR is the ability to maintain a sustained molecular response* after stopping TKI therapy in patients with Ph+ CML-CP. TFR requires scheduled monitoring of BCR-ABL1 levels to identify possible loss of molecular response.

Comment: With the updated dosing recommendations, patients with early (chronic) phase CML who have been taking Tasigna for three years or more, and whose leukemia has responded to treatment according to specific criteria as detected by a test that has received FDA marketing authorization, may be eligible to stop taking Tasigna. However it is important to note that any discontinuation of treatment still means patients must be regularly monitored for disease recurrence.