Novartis drug Tasigna is approved by FDA as first and only CML therapy with treatment-free Remission data in its label.
The U.S. Food and Drug Administration (FDA) approved the inclusion of treatment-free remission (TFR) data in the Novartis Tasigna (nilotinib) U.S. 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 percent) 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.
With the label update, Tasigna is the only TKI that provides defined, approved criteria to attempt and monitor TFR. This approval follows a priority review for a supplemental New Drug Application (sNDA) for Tasigna seeking the addition of TFR information and is based on safety and efficacy results from the 96-week analyses of two open label trials, ENESTfreedom and ENESTop.
The trials evaluated the potential to maintain MMR (BCR-ABL1 <= 0.1 percent) after stopping Tasigna therapy among eligible adult patients with Ph+ CML-CP. Patients in the trials had achieved a sustained MR4.5 with Tasigna in both the first-line setting or after switching from Gleevec (imatinib mesylate)**1.
The trials demonstrated that almost half of the Ph+ CML-CP patients who discontinued Tasigna remained in TFR approximately two years after stopping treatment1. Among patients who did lose molecular response during the TFR phase of the trials, nearly all regained MMR when Tasigna therapy was promptly reinitiated1. The safety data are consistent with previously published studies and the known safety profile of Tasigna1.
The TFR data in the Tasigna label approved by the FDA included the use of the MolecularMD MRDx BCR-ABL test, an FDA-authorized companion diagnostic validated to measure BCR-ABL transcript levels down to MR4.51.
Discontinuation of Tasigna should only be attempted under the close supervision of a physician. Frequently scheduled patient monitoring after Tasigna discontinuation is required so that possible loss of MMR and MR4.0 (BCR-ABL1 IS <= 0.01 percent) is quickly identified and treatment re-initiation is started promptly1.
*No loss of MMR (BCR-ABL1 <= 0.1 percent) in newly diagnosed patients, and no loss of MMR or no confirmed loss of MR4.0 (BCR-ABL1 <= 0.01 percent) in patients resistant or intolerant to prior treatment including imatinib.
**Known as Glivec® (imatinib) tablets outside the U.S. and Canada.
1 Tasigna (nilotinib) Prescribing Information. East Hanover, New Jersey, USA: Novartis Pharmaceuticals Corporation; December 2017.
Filed Under: Drug Discovery